{"protocolSection":{"identificationModule":{"nctId":"NCT00755807","orgStudyIdInfo":{"id":"11666"},"secondaryIdInfos":[{"id":"F1J-US-HMFR","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"Duloxetine for Multiple Sclerosis Pain","officialTitle":"Duloxetine in Patients With Central Neuropathic Pain Due to Multiple Sclerosis."},"statusModule":{"statusVerifiedDate":"2011-11","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2008-10"},"primaryCompletionDateStruct":{"date":"2010-08","type":"ACTUAL"},"completionDateStruct":{"date":"2010-11","type":"ACTUAL"},"studyFirstSubmitDate":"2008-09-17","studyFirstSubmitQcDate":"2008-09-17","studyFirstPostDateStruct":{"date":"2008-09-19","type":"ESTIMATED"},"resultsFirstSubmitDate":"2011-06-13","resultsFirstSubmitQcDate":"2011-11-04","resultsFirstPostDateStruct":{"date":"2011-12-09","type":"ESTIMATED"},"lastUpdateSubmitDate":"2011-11-04","lastUpdatePostDateStruct":{"date":"2011-12-09","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"This study is designed to primarily assess the efficacy and safety of duloxetine 60-120 mg once daily (QD) compared with placebo on the reduction of pain severity in participants with central neuropathic pain due to Multiple Sclerosis.","detailedDescription":"Study is a multicenter, randomized, double-blind, parallel, placebo-controlled, 20-week trial with 4 study periods. Participants who screen successfully (Study Period I) will be randomized in a 1:1 fashion to duloxetine 60 mg QD or placebo. Starting with Study Period II, participants will be treated in a double-blind manner for 6 weeks. Participants who complete the 6-week, double-blind period will have the opportunity to participate in a 12-week, open-label, flexible-dose portion of the study (Study Period III). Study Period IV is a taper phase designed to reduce the occurrence of discontinuation adverse events. Participants may enter Study Period IV at any time after Visit 3."},"conditionsModule":{"conditions":["Multiple Sclerosis"],"keywords":["Central Neuropathic Pain","Multiple Sclerosis"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":239,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Placebo","type":"PLACEBO_COMPARATOR","interventionNames":["Drug: Placebo"]},{"label":"Duloxetine","type":"EXPERIMENTAL","interventionNames":["Drug: Duloxetine Hydrochloride (HCI)"]}],"interventions":[{"type":"DRUG","name":"Duloxetine Hydrochloride (HCI)","description":"Participants received 30 mg duloxetine (po, QD) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period. If the participant completes the double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).","armGroupLabels":["Duloxetine"],"otherNames":["LY248686","Cymbalta"]},{"type":"DRUG","name":"Placebo","description":"Participants received placebo oral (po), once daily (QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 milligrams \\[mg\\] QD for 12 weeks).","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline in the Weekly 24-Hour Average Pain Scores at Week 6 (Acute Phase)","description":"24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean, with scores ranging from 0 (no pain) to 10 (worst possible pain). Participants should complete electronic diary each day upon awakening. The 11-point Likert scale was used for assessment of 24-hour average pain and evaluated as weekly means. Scores range from 0 (no pain) to 10 (worst possible pain). The Least Squares Mean (LS Mean) Value was adjusted for investigative site and baseline severity.","timeFrame":"Baseline, 6 weeks"}],"secondaryOutcomes":[{"measure":"Change From Baseline in the Weekly 24-Hour Average Pain Scores up to Week 6 (Acute Phase)","description":"This is a nominal outcome reflecting whether or not a clinically-important efficacy outcome (≥30% or ≥50% pain reduction from baseline) was achieved at endpoint. It is based on a comparison between baseline and endpoint scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by participants in their diaries.","timeFrame":"Baseline, 6 weeks"},{"measure":"Patient Global Impressions of Improvement Scale (PGI-I) at 6 Weeks","description":"A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). The Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity.","timeFrame":"6 weeks"},{"measure":"Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 6 (Acute Phase)","description":"Measures pain severity and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst, least, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing pain interference in past 24 hours, such as general activity, mood, normal work, relations with other people, and sleep. Average interference=average of non-missing scores of individual interference items. Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity.","timeFrame":"Baseline, 6 weeks"},{"measure":"Change From Baseline in the Clinical Global Impression of Severity Scale (CGI-S) at 6 Weeks (Acute Phase)","description":"Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity.","timeFrame":"Baseline, 6 weeks"},{"measure":"Change From Baseline in the Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at 6 Weeks (Acute Phase)","description":"A 54 question measure covers 12 domains; assesses mental and physical health. Each domain score is converted into a 0-100 score based on individual item responses; higher scores=better health status. The physical health composite score is a weighted average of the physical health scales, such as physical function, health perceptions, and energy. The mental health composite score is a weighted average of the mental health scales, such as overall quality of life, cognitive function, and health distress. The Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity.","timeFrame":"Baseline, 6 weeks"},{"measure":"Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 6","description":"C-SSRS scale captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a \"yes\" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a \"yes\" answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal act: a \"yes\" answer to actual attempt or completed suicide.","timeFrame":"6 weeks"},{"measure":"Change From Baseline in the Weekly Mean of Night Pain Scores at Week 6 (Acute Phase)","description":"Weekly mean of the night pain severity scores recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Participants should complete the electronic diary each day upon awakening. The Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity.","timeFrame":"Baseline, 6 weeks"},{"measure":"Change From Baseline in the Beck Depression Inventory II (BDI-II) Question #9 at Week 6 (Acute Phase)","description":"The BDI-II is completed by the participant to rate the severity of depressive symptoms and any improvement during the course of the trial. The total score ranges from 0 to 63 with higher the score indicating more severe depressive symptoms. Question #9 is suicidal thoughts and wishes with a score ranging from 0 to 3.","timeFrame":"Baseline, 6 weeks"},{"measure":"Number of Participants Who Discontinued During the Acute Phase (by Week 6)","timeFrame":"Baseline through 6 weeks"},{"measure":"Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Acute Phase","description":"Summary tables of serious adverse events (SAEs) and all other non-serious adverse events are located in the Reported Adverse Event Module.","timeFrame":"Baseline through 6 weeks"},{"measure":"Number of Participants With Adverse Events (AEs) Resulting in Discontinuation From Baseline During the Acute Phase","timeFrame":"Baseline through 6 weeks"},{"measure":"Change From Baseline in Blood Pressure at Week 6 (Acute Phase)","timeFrame":"Baseline, 6 weeks"},{"measure":"Change From Baseline in Pulse Rate at Week 6 (Acute Phase)","timeFrame":"Baseline, 6 weeks"},{"measure":"Change From Baseline in Weight at Week 6 (Acute Phase)","timeFrame":"Baseline, 6 weeks"},{"measure":"Patient Global Impressions of Improvement Scale (PGI-I) Score at 18 Weeks","description":"A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The scores range from 1 (very much better) to 7 (very much worse).","timeFrame":"18 weeks"},{"measure":"Change From Baseline in Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 18","description":"BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items.","timeFrame":"Baseline (end of acute phase/Week 6), Endpoint (Week 18)"},{"measure":"Change From Baseline in the Clinical Global Impression of Severity Scale (CGI-S) Score at Week 18 (Open-label Extension Phase)","description":"Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).","timeFrame":"Baseline (6 weeks), Endpoint (18 weeks)"},{"measure":"Change From Baseline in Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at Week 18 (Open-label Extension Phase)","description":"A 54 question measure covers 12 domains; assesses mental and physical health. Each domain score is converted into a 0-100 score based on individual item responses; higher scores=better health status. The physical health composite score is a weighted average of the physical health scales, such as physical function, health perceptions, and energy. The mental health composite score is a weighted average of the mental health scales, such as overall quality of life, cognitive function, and health distress.","timeFrame":"Baseline (6 weeks), Endpoint (18 weeks)"},{"measure":"Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 18","description":"C-SSRS scale captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a \"yes\" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a \"yes\" answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal act: a \"yes\" answer to actual attempt or completed suicide.","timeFrame":"18 weeks"},{"measure":"Change in the Weekly Mean of the Night Pain Scores From Week 6 Through Week 18 (Open-label Extension Phase)","description":"Weekly mean of the night pain severity scores recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Participants should complete the electronic diary each day upon awakening. Each weekly mean change represents change relative to week 6, the baseline of the extension phase.","timeFrame":"Baseline (6 weeks) through Endpoint (18 weeks)"},{"measure":"Change From Baseline in Beck Depression Inventory II (BDI-II), Question #9 at Week 18 (Open-label Extension Phase)","description":"The BDI-II is completed by the participant to rate the severity of depressive symptoms and any improvement during the course of the trial. The total score ranges from 0 to 63 with higher the score indicating more severe depressive symptoms. Question #9 is suicidal thoughts and wishes with the score ranging from 0 to 3.","timeFrame":"Baseline (6 weeks), Endpoint (18 weeks)"},{"measure":"Number of Participants Who Discontinued During the Open-label Extension Phase (by Week 18)","timeFrame":"Baseline (6 weeks) through Endpoint (18 weeks)"},{"measure":"Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Open-label Extension Phase","description":"Summary tables of serious adverse events (SAEs) and all other non-serious adverse events are located in the Reported Adverse Event Module.","timeFrame":"Baseline (6 weeks) through Endpoint (18 weeks)"},{"measure":"Number of Participants With Adverse Events (AEs) Resulting in Discontinuation During the Open-label Extension Phase","timeFrame":"Baseline (6 weeks) through Endpoint (18 weeks)"},{"measure":"Change From Baseline in Blood Pressure at Week 18 (Open-label Extension Phase)","timeFrame":"Baseline (6 weeks), Endpoint (18 weeks)"},{"measure":"Change From Baseline in Pulse Rate at Week 18 (Open-label Extension Phase)","timeFrame":"Baseline (6 weeks), endpoint (18 weeks)"},{"measure":"Change From Baseline in Weight at Week 18 (Open-label Extension Phase)","timeFrame":"Baseline (6 weeks), Endpoint (18 weeks)"}],"otherOutcomes":[{"measure":"Change From Baseline in Bicarbonate (HCO3) at Week 6 (Acute Phase)","description":"Change from baseline to acute phase endpoint in laboratory assessment for bicarbonate, HCO3.","timeFrame":"Baseline, 6 weeks"},{"measure":"Change From Baseline in Creatinine at Week 6 (Acute Phase)","description":"Change from baseline to acute phase endpoint in laboratory assessment of creatinine.","timeFrame":"Baseline, 6 weeks"},{"measure":"Change From Baseline in the Platelet Count at Week 6 (Acute Phase)","description":"Change from baseline to acute phase endpoint in laboratory assessment of platelet count.","timeFrame":"Baseline, 6 weeks"},{"measure":"Change From Baseline in Inorganic Phosphorus at Week 6 (Acute Phase)","description":"Change from baseline to acute phase endpoint in laboratory assessment of inorganic phosphorus.","timeFrame":"Baseline, 6 weeks"},{"measure":"Change From Baseline in Uric Acid at Week 6 (Acute Phase)","description":"Change from baseline to acute phase endpoint in laboratory assessment of uric acid.","timeFrame":"Baseline, 6 weeks"},{"measure":"Change From Baseline in Monocytes at Week 18 (Open-label Extension Phase)","timeFrame":"Baseline (6 weeks), Endpoint (18 weeks)"},{"measure":"Change From Baseline in Sodium at Week 18 (Open-label Extension Phase)","timeFrame":"Baseline (6 weeks), Endpoint (18 weeks)"},{"measure":"Change From Baseline in Total Protein at Week 18 (Open-label Extension Phase)","timeFrame":"Baseline (6 weeks), Endpoint (18 weeks)"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Have central neuropathic pain due to multiple sclerosis (MS) based on the disease diagnostic criteria\n* Adult males or females\n* Have a score of 4 or greater on the daily 24-hour average pain score\n* Females must test negative for pregnancy at study entry\n* Complete the daily diaries for at least 70% of the days of the study\n* Participants may continue other prescription and nonprescription analgesic pain medications as long as the dose has been stable for 1 month prior to study entry, and they agree to maintain that stable dose throughout the study Disease Diagnostic Criteria:\n\n  * Diagnosis of MS at least 1 year prior to study entry\n  * No MS flares or change in disease treatment for the 3 months prior to study entry\n  * Daily pain due to MS for a minimum of 3 months prior to study entry\n\nExclusion Criteria:\n\n* Are currently in a clinical trial of MS disease-modifying therapy\n* Have pain that cannot be clearly differentiated from causes other than MS\n* Any current or historical diagnosis of mania, bipolar disorder, psychosis, or schizoaffective disorder\n* History of substance abuse or dependence\n* Are pregnant or breast-feeding","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 Hours, EST)","affiliation":"Eli Lilly and Company","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Birmingham","state":"Alabama","zip":"35294","country":"United States","geoPoint":{"lat":33.52066,"lon":-86.80249}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Phoenix","state":"Arizona","zip":"85018","country":"United States","geoPoint":{"lat":33.44838,"lon":-112.07404}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Tucson","state":"Arizona","zip":"85741","country":"United States","geoPoint":{"lat":32.22174,"lon":-110.92648}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Aurora","state":"Colorado","zip":"80045","country":"United States","geoPoint":{"lat":39.72943,"lon":-104.83192}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Denver","state":"Colorado","zip":"80204","country":"United States","geoPoint":{"lat":39.73915,"lon":-104.9847}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Bradenton","state":"Florida","zip":"34205","country":"United States","geoPoint":{"lat":27.49893,"lon":-82.57482}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Lenexa","state":"Kansas","zip":"66214","country":"United States","geoPoint":{"lat":38.95362,"lon":-94.73357}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Roseville","state":"Michigan","zip":"48066","country":"United States","geoPoint":{"lat":42.49726,"lon":-82.93714}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"St Louis","state":"Missouri","zip":"63141","country":"United States","geoPoint":{"lat":38.62727,"lon":-90.19789}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Charlotte","state":"North Carolina","zip":"28207","country":"United States","geoPoint":{"lat":35.22709,"lon":-80.84313}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Bismarck","state":"North Dakota","zip":"58501","country":"United States","geoPoint":{"lat":46.80833,"lon":-100.78374}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Akron","state":"Ohio","zip":"44320","country":"United States","geoPoint":{"lat":41.08144,"lon":-81.51901}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Cincinnati","state":"Ohio","zip":"45219","country":"United States","geoPoint":{"lat":39.12711,"lon":-84.51439}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Oklahoma City","state":"Oklahoma","zip":"73109","country":"United States","geoPoint":{"lat":35.46756,"lon":-97.51643}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Portland","state":"Oregon","zip":"97225","country":"United States","geoPoint":{"lat":45.52345,"lon":-122.67621}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Allentown","state":"Pennsylvania","zip":"18102","country":"United States","geoPoint":{"lat":40.60843,"lon":-75.49018}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Melsbroek","zip":"1820","country":"Belgium","geoPoint":{"lat":50.91559,"lon":4.47985}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Winnipeg","state":"Manitoba","zip":"R3A 1R9","country":"Canada","geoPoint":{"lat":49.8844,"lon":-97.14704}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Greenfield Park","state":"Quebec","zip":"J4V 2J2","country":"Canada","geoPoint":{"lat":45.48649,"lon":-73.46223}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Lublin","zip":"20-090","country":"Poland","geoPoint":{"lat":51.25058,"lon":22.57009}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Szczecin","zip":"70-215","country":"Poland","geoPoint":{"lat":53.42894,"lon":14.55302}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Wroclaw","zip":"50-556","country":"Poland","geoPoint":{"lat":51.10286,"lon":17.03006}}]},"referencesModule":{"seeAlsoLinks":[{"label":"Lilly Clinical Trial Registry","url":"http://www.lillytrials.com"}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Duloxetine","description":"Participants received 30 milligrams (mg) duloxetine (oral \\[po\\], once daily \\[QD\\]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period. If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks)."},{"id":"FG001","title":"Placebo","description":"Participants received placebo po, QD for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks)."}],"periods":[{"title":"Acute Phase","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"118"},{"groupId":"FG001","numSubjects":"121"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"100"},{"groupId":"FG001","numSubjects":"109"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"18"},{"groupId":"FG001","numSubjects":"12"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"5"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"3"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]}]},{"title":"Open-label Extension Phase","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"100"},{"groupId":"FG001","numSubjects":"109"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"82"},{"groupId":"FG001","numSubjects":"93"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"18"},{"groupId":"FG001","numSubjects":"16"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"7"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"3"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"3"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Sponsor Decision","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Duloxetine","description":"Participants received 30 milligrams (mg) duloxetine (oral \\[po\\], once daily \\[QD\\]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period. If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks)."},{"id":"BG001","title":"Placebo","description":"Participants received placebo po, QD for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks)."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"118"},{"groupId":"BG001","value":"121"},{"groupId":"BG002","value":"239"}]}],"measures":[{"title":"Age Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"50.77","spread":"9.67"},{"groupId":"BG001","value":"52.67","spread":"9.07"},{"groupId":"BG002","value":"51.73","spread":"9.40"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"86"},{"groupId":"BG001","value":"93"},{"groupId":"BG002","value":"179"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"32"},{"groupId":"BG001","value":"28"},{"groupId":"BG002","value":"60"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"African","categories":[{"measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"15"}]}]},{"title":"Caucasian","categories":[{"measurements":[{"groupId":"BG000","value":"109"},{"groupId":"BG001","value":"112"},{"groupId":"BG002","value":"221"}]}]},{"title":"Hispanic","categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"2"}]}]},{"title":"Native American","categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Belgium","categories":[{"measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"14"}]}]},{"title":"Canada","categories":[{"measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"11"}]}]},{"title":"Poland","categories":[{"measurements":[{"groupId":"BG000","value":"20"},{"groupId":"BG001","value":"20"},{"groupId":"BG002","value":"40"}]}]},{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"87"},{"groupId":"BG001","value":"87"},{"groupId":"BG002","value":"174"}]}]}]},{"title":"Multiple Sclerosis (MS) Diagnosis Subtype","description":"National MS Society diagnosis subtypes:\n\nPrimary progressive: initially progressive disease with no plateaus or remissions; or occasional plateau and acute, minor improvements.\n\nProgressive-relapsing: initial disease progression, but with clear, acute relapses, with or without full recovery from such relapses over time.\n\nRelapsing-remitting: clearly defined acute attacks with full or partial recovery; no disease progression between attacks.\n\nSecondary-progressive: initially relapsing-remitting, then progressive at a variable rate, with possible occasional relapse and minor remission.","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Primary-Progressive","categories":[{"measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"16"},{"groupId":"BG002","value":"26"}]}]},{"title":"Progressive-Relapsing","categories":[{"measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"10"}]}]},{"title":"Relapsing-Remitting","categories":[{"measurements":[{"groupId":"BG000","value":"81"},{"groupId":"BG001","value":"72"},{"groupId":"BG002","value":"153"}]}]},{"title":"Secondary-Progressive","categories":[{"measurements":[{"groupId":"BG000","value":"23"},{"groupId":"BG001","value":"27"},{"groupId":"BG002","value":"50"}]}]}]},{"title":"Duration of MS","description":"How long the participants have had MS.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"11.05","spread":"7.48"},{"groupId":"BG001","value":"11.40","spread":"8.49"},{"groupId":"BG002","value":"11.23","spread":"7.99"}]}]}]},{"title":"Duration of central neuropathic pain (CNP) due to MS (n=118, 120)","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"6.18","spread":"5.88"},{"groupId":"BG001","value":"7.56","spread":"6.69"},{"groupId":"BG002","value":"6.88","spread":"6.33"}]}]}]},{"title":"Weekly 24-Hour Average Pain","description":"This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the average pain severity over the last 24 hours. Scores are based on daily assessments recorded by participants in their diaries.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"6.49","spread":"1.41"},{"groupId":"BG001","value":"6.31","spread":"1.33"},{"groupId":"BG002","value":"6.40","spread":"1.37"}]}]}]},{"title":"Brief Pain Inventory (BPI) Average Interference (Duloxetine n=116, Placebo n=119)","description":"A self-reported scale that measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The average Interference scores range from 0 (does not interfere) to 10 (completely interferes).","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"5.50","spread":"1.98"},{"groupId":"BG001","value":"5.24","spread":"2.01"},{"groupId":"BG002","value":"5.37","spread":"2.00"}]}]}]},{"title":"BPI Average Pain (Duloxetine n=116, Placebo n=119)","description":"A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"6.09","spread":"1.50"},{"groupId":"BG001","value":"5.91","spread":"1.33"},{"groupId":"BG002","value":"6.00","spread":"1.42"}]}]}]},{"title":"Multiple Sclerosis Quality of Life (MS-QOL-54) Overall Quality of Life Subsection","description":"The MS-QOL-54 is self-reported and consists of 54 questions covering 12 domains: physical function, role limitations due to physical problems, role limitations due to emotional problems, emotional wellbeing, energy, health perceptions, social function, cognitive function, health distress, satisfaction with sexual function, change in health, and overall quality of life. Each domain score is converted into a 0-100 score based on the individual item responses, with higher scores indicating better health status or functioning. Number of participants (n) for duloxetine=116; placebo=119.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"58.06","spread":"18.61"},{"groupId":"BG001","value":"61.78","spread":"18.80"},{"groupId":"BG002","value":"59.94","spread":"18.76"}]}]}]},{"title":"Expanded Disability Status Scale ([EDSS], n=118, 120)","description":"The EDSS is a method of quantifying disability in multiple sclerosis. The EDSS quantifies disability in 8 Functional Systems (pyramidal, cerebellar, brain stem, sensory, bowel and bladder, visual, cerebral, and other) and allows neurologists to assign a functional system score in each. An EDSS of 0.0 is a normal neurological examination. The scores increase in increments of 0.5 starting with 1.0 (no disability, minimal signs in 1 functional system) to 10.0 (death due to MS).","paramType":"MEDIAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"4.00","spread":"2.01"},{"groupId":"BG001","value":"4.00","spread":"1.78"},{"groupId":"BG002","value":"4.00","spread":"1.89"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change From Baseline in the Weekly 24-Hour Average Pain Scores at Week 6 (Acute Phase)","description":"24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean, with scores ranging from 0 (no pain) to 10 (worst possible pain). Participants should complete electronic diary each day upon awakening. The 11-point Likert scale was used for assessment of 24-hour average pain and evaluated as weekly means. Scores range from 0 (no pain) to 10 (worst possible pain). The Least Squares Mean (LS Mean) Value was adjusted for investigative site and baseline severity.","populationDescription":"Number of randomized participants with baseline and at least 1 post-baseline value.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on a scale","timeFrame":"Baseline, 6 weeks","groups":[{"id":"OG000","title":"Duloxetine","description":"Participants received 30 milligrams (mg) duloxetine (oral \\[po\\], once daily \\[QD\\]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period."},{"id":"OG001","title":"Placebo","description":"Participants received placebo (po, QD) for 6 weeks (acute phase)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"103"},{"groupId":"OG001","value":"115"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.83","spread":"0.17"},{"groupId":"OG001","value":"-1.07","spread":"0.16"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Null hypothesis: no difference between duloxetine and placebo on pain severity reduction as measured by weekly mean of the daily 24-hour average pain scores in participants assessed at 6 weeks. Sample size is determined using 2-sided t-test with significance level of 0.05, and 5% of randomized participants without post-baseline data due to very early discontinuation. With 119 participants per arm, study has approximately 80% power to detect an effect size of 0.375 on treatment group difference.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.001","pValueComment":"The a priori threshold for statistical significance was 0.05.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed model repeated measures (MMRM):Change from Baseline=Baseline+Treatment+Investigator+Week+Treatment\\*Week+Baseline\\*Week,participant random effect.","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Change From Baseline in the Weekly 24-Hour Average Pain Scores up to Week 6 (Acute Phase)","description":"This is a nominal outcome reflecting whether or not a clinically-important efficacy outcome (≥30% or ≥50% pain reduction from baseline) was achieved at endpoint. It is based on a comparison between baseline and endpoint scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by participants in their diaries.","populationDescription":"Number of randomized participants with baseline and at least 1 post-baseline value. Last-observation-carried-forward (LOCF) imputation was implemented for participants with early discontinuation. Baseline-observation-carried-forward (BOCF) imputation was implemented for participants with early discontinuation.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Baseline, 6 weeks","groups":[{"id":"OG000","title":"Duloxetine","description":"Participants received 30 milligrams (mg) duloxetine (oral \\[po\\], once daily \\[QD\\]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period."},{"id":"OG001","title":"Placebo","description":"Participants received placebo (po, QD) for 6 weeks (acute phase)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"115"},{"groupId":"OG001","value":"119"}]}],"classes":[{"title":"≥30% Reduction (LOCF)","categories":[{"measurements":[{"groupId":"OG000","value":"47"},{"groupId":"OG001","value":"32"}]}]},{"title":"≥50% Reduction (LOCF)","categories":[{"measurements":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"19"}]}]},{"title":"≥30% Reduction (BOCF)","categories":[{"measurements":[{"groupId":"OG000","value":"44"},{"groupId":"OG001","value":"29"}]}]},{"title":"≥50% Reduction (BOCF)","categories":[{"measurements":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"16"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.027","pValueComment":"P-value is for the 30% Reduction (LOCF). P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.","statisticalMethod":"Fisher Exact","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.246","pValueComment":"P-value is for 50% Reduction (LOCF). P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.","statisticalMethod":"Fisher Exact","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.024","pValueComment":"P-value is for the 30% Reduction (BOCF). P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.","statisticalMethod":"Fisher Exact","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.165","pValueComment":"P-value is for 50% Reduction (BOCF). P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.","statisticalMethod":"Fisher Exact","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Patient Global Impressions of Improvement Scale (PGI-I) at 6 Weeks","description":"A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). The Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity.","populationDescription":"Number of randomized participants with at least 1 post-baseline value. Last-observation-carried-forward (LOCF) imputation was implemented.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on a scale","timeFrame":"6 weeks","groups":[{"id":"OG000","title":"Duloxetine","description":"Participants received 30 milligrams (mg) duloxetine (oral \\[po\\], once daily \\[QD\\]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period."},{"id":"OG001","title":"Placebo","description":"Participants received placebo (po, QD) for 6 weeks (acute phase)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"106"},{"groupId":"OG001","value":"116"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3.27","spread":"0.11"},{"groupId":"OG001","value":"3.48","spread":"0.10"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.121","pValueComment":"P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"ANOVA","statisticalComment":"Analysis of Variance (ANOVA) Model: PGI improvement at Endpoint = Treatment + Investigator.","paramType":"Mean Difference (Final Values)","paramValue":"0.21","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.06","ciUpperLimit":"0.49","estimateComment":"The mean difference is for placebo - duloxetine."}]},{"type":"SECONDARY","title":"Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 6 (Acute Phase)","description":"Measures pain severity and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst, least, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing pain interference in past 24 hours, such as general activity, mood, normal work, relations with other people, and sleep. Average interference=average of non-missing scores of individual interference items. Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity.","populationDescription":"Number of randomized participants with baseline and at least 1 post-baseline value.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on a scale","timeFrame":"Baseline, 6 weeks","groups":[{"id":"OG000","title":"Duloxetine","description":"Participants received 30 milligrams (mg) duloxetine (oral \\[po\\], once daily \\[QD\\]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period."},{"id":"OG001","title":"Placebo","description":"Participants received placebo (po, QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"106"},{"groupId":"OG001","value":"116"}]}],"classes":[{"title":"BPI Severity for Worst Pain","categories":[{"measurements":[{"groupId":"OG000","value":"-1.95","spread":"0.21"},{"groupId":"OG001","value":"-1.29","spread":"0.20"}]}]},{"title":"BPI Severity for Least Pain","categories":[{"measurements":[{"groupId":"OG000","value":"-1.20","spread":"0.18"},{"groupId":"OG001","value":"-0.72","spread":"0.17"}]}]},{"title":"BPI Severity for Average Pain","categories":[{"measurements":[{"groupId":"OG000","value":"-1.36","spread":"0.19"},{"groupId":"OG001","value":"-0.84","spread":"0.17"}]}]},{"title":"BPI Severity for Pain Right Now","categories":[{"measurements":[{"groupId":"OG000","value":"-1.91","spread":"0.21"},{"groupId":"OG001","value":"-1.02","spread":"0.20"}]}]},{"title":"BPI Interference for General Activity","categories":[{"measurements":[{"groupId":"OG000","value":"-1.81","spread":"0.23"},{"groupId":"OG001","value":"-1.29","spread":"0.22"}]}]},{"title":"BPI Interference for Mood","categories":[{"measurements":[{"groupId":"OG000","value":"-1.91","spread":"0.24"},{"groupId":"OG001","value":"-1.25","spread":"0.22"}]}]},{"title":"BPI Interference for Walking Ability","categories":[{"measurements":[{"groupId":"OG000","value":"-1.47","spread":"0.25"},{"groupId":"OG001","value":"-0.91","spread":"0.24"}]}]},{"title":"BPI Interference for Normal Work","categories":[{"measurements":[{"groupId":"OG000","value":"-1.51","spread":"0.24"},{"groupId":"OG001","value":"-1.18","spread":"0.22"}]}]},{"title":"BPI Interference for Relations With Others","categories":[{"measurements":[{"groupId":"OG000","value":"-1.72","spread":"0.22"},{"groupId":"OG001","value":"-1.22","spread":"0.20"}]}]},{"title":"BPI Interference for Sleep","categories":[{"measurements":[{"groupId":"OG000","value":"-2.01","spread":"0.22"},{"groupId":"OG001","value":"-1.59","spread":"0.21"}]}]},{"title":"BPI Interference for Enjoyment Of Life","categories":[{"measurements":[{"groupId":"OG000","value":"-1.82","spread":"0.24"},{"groupId":"OG001","value":"-1.65","spread":"0.23"}]}]},{"title":"BPI Mean Interference Score","categories":[{"measurements":[{"groupId":"OG000","value":"-1.77","spread":"0.19"},{"groupId":"OG001","value":"-1.32","spread":"0.18"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.016","pValueComment":"P-value is for BPI Severity for Worst Pain score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"ANCOVA","statisticalComment":"Model: Change from Baseline = Treatment + Investigator + Baseline Value.","paramType":"Mean Difference (Final Values)","paramValue":"0.66","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.12","ciUpperLimit":"1.20","estimateComment":"The mean difference is for placebo - duloxetine."},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.043","pValueComment":"P-value is for BPI Severity for Least Pain score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"ANCOVA","statisticalComment":"Model: Change from Baseline = Treatment + Investigator + Baseline Value.","paramType":"Mean Difference (Final Values)","paramValue":"0.48","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.02","ciUpperLimit":"0.95","estimateComment":"The mean difference is for placebo - duloxetine."},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.030","pValueComment":"P-value is for BPI Severity for Average Pain score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"ANCOVA","statisticalComment":"Model: Change from Baseline = Treatment + Investigator + Baseline Value.","paramType":"Mean Difference (Final Values)","paramValue":"0.52","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.05","ciUpperLimit":"0.99","estimateComment":"The mean difference is for placebo - duloxetine."},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.001","pValueComment":"P-value is for BPI Severity for Pain Right Now score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"ANCOVA","statisticalComment":"Model: Change from Baseline = Treatment + Investigator + Baseline Value.","paramType":"Mean Difference (Final Values)","paramValue":"0.89","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.36","ciUpperLimit":"1.43","estimateComment":"The mean difference is for placebo - duloxetine."},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.083","pValueComment":"P-value is for BPI Interference for General Activity score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"ANCOVA","statisticalComment":"Model: Change from Baseline = Treatment + Investigator + Baseline Value.","paramType":"Mean Difference (Final Values)","paramValue":"0.52","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.07","ciUpperLimit":"1.11","estimateComment":"The mean difference is for placebo - duloxetine."},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.034","pValueComment":"P-value is for BPI Interference for Mood score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"ANCOVA","statisticalComment":"Model: Change from Baseline = Treatment + Investigator + Baseline Value.","paramType":"Mean Difference (Final Values)","paramValue":"0.66","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.05","ciUpperLimit":"1.27","estimateComment":"The mean difference is for placebo - duloxetine."},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.089","pValueComment":"P-value is for BPI Interference for Walking Ability score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"ANCOVA","statisticalComment":"Model: Change from Baseline = Treatment + Investigator + Baseline Value.","paramType":"Mean Difference (Final Values)","paramValue":"0.55","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.08","ciUpperLimit":"1.19","estimateComment":"The mean difference is for placebo - duloxetine."},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.291","pValueComment":"P-value is for BPI Interference for Normal Work score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"ANCOVA","statisticalComment":"Model: Change from Baseline = Treatment + Investigator + Baseline Value.","paramType":"Mean Difference (Final Values)","paramValue":"0.33","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.28","ciUpperLimit":"0.93","estimateComment":"The mean difference is for placebo - duloxetine."},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.077","pValueComment":"P-value is for BPI Interference for Relations With Others score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"ANCOVA","statisticalComment":"Model: Change from Baseline = Treatment + Investigator + Baseline Value.","paramType":"Mean Difference (Final Values)","paramValue":"0.50","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.06","ciUpperLimit":"1.05","estimateComment":"The mean difference is for placebo - duloxetine."},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.148","pValueComment":"P-value is for BPI Interference for Sleep score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"ANCOVA","statisticalComment":"Model: Change from Baseline = Treatment + Investigator + Baseline Value.","paramType":"Mean Difference (Final Values)","paramValue":"0.41","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.15","ciUpperLimit":"0.97","estimateComment":"The mean difference is for placebo - duloxetine."},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.582","pValueComment":"P-value is for BPI Interference for Enjoyment Of Life score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"ANCOVA","statisticalComment":"Model: Change from Baseline = Treatment + Investigator + Baseline Value.","paramType":"Mean Difference (Final Values)","paramValue":"0.17","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.45","ciUpperLimit":"0.79","estimateComment":"The mean difference is for placebo - duloxetine."},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.067","pValueComment":"P-value is for BPI Mean Interference score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"ANCOVA","statisticalComment":"Model: Change from Baseline = Treatment + Investigator + Baseline Value.","paramType":"Mean Difference (Final Values)","paramValue":"0.45","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.03","ciUpperLimit":"0.94","estimateComment":"The mean difference is for placebo - duloxetine."}]},{"type":"SECONDARY","title":"Change From Baseline in the Clinical Global Impression of Severity Scale (CGI-S) at 6 Weeks (Acute Phase)","description":"Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity.","populationDescription":"Number of randomized participants with baseline and at least 1 post-baseline value.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on a scale","timeFrame":"Baseline, 6 weeks","groups":[{"id":"OG000","title":"Duloxetine","description":"Participants received 30 milligrams (mg) duloxetine (oral \\[po\\], once daily \\[QD\\]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period."},{"id":"OG001","title":"Placebo","description":"Participants received placebo (po, QD) for 6 weeks (acute phase)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"111"},{"groupId":"OG001","value":"114"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.67","spread":"0.09"},{"groupId":"OG001","value":"-0.44","spread":"0.08"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.041","pValueComment":"P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"ANCOVA","statisticalComment":"Model: Change from Baseline = Treatment + Investigator + Baseline Value.","paramType":"Mean Difference (Final Values)","paramValue":"0.23","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.01","ciUpperLimit":"0.45","estimateComment":"The mean difference is for placebo - duloxetine."}]},{"type":"SECONDARY","title":"Change From Baseline in the Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at 6 Weeks (Acute Phase)","description":"A 54 question measure covers 12 domains; assesses mental and physical health. Each domain score is converted into a 0-100 score based on individual item responses; higher scores=better health status. The physical health composite score is a weighted average of the physical health scales, such as physical function, health perceptions, and energy. The mental health composite score is a weighted average of the mental health scales, such as overall quality of life, cognitive function, and health distress. The Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity.","populationDescription":"Number of randomized participants with baseline and at least 1 post-baseline value.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on a scale","timeFrame":"Baseline, 6 weeks","groups":[{"id":"OG000","title":"Duloxetine","description":"Participants received 30 milligrams (mg) duloxetine (oral \\[po\\], once daily \\[QD\\]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period."},{"id":"OG001","title":"Placebo","description":"Participants received placebo (po, QD) for 6 weeks (acute phase)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"106"},{"groupId":"OG001","value":"116"}]}],"classes":[{"title":"Physical Health Composite (N=106, 116)","categories":[{"measurements":[{"groupId":"OG000","value":"6.11","spread":"1.15"},{"groupId":"OG001","value":"5.12","spread":"1.08"}]}]},{"title":"Mental Health Composite (N=106, 116)","categories":[{"measurements":[{"groupId":"OG000","value":"5.81","spread":"1.44"},{"groupId":"OG001","value":"4.59","spread":"1.35"}]}]},{"title":"Physical Health (N=106, 116)","categories":[{"measurements":[{"groupId":"OG000","value":"3.35","spread":"1.51"},{"groupId":"OG001","value":"2.65","spread":"1.42"}]}]},{"title":"Health Perceptions (N=106, 116)","categories":[{"measurements":[{"groupId":"OG000","value":"1.41","spread":"1.39"},{"groupId":"OG001","value":"1.35","spread":"1.31"}]}]},{"title":"Energy Subsection Score (N=106, 116)","categories":[{"measurements":[{"groupId":"OG000","value":"6.54","spread":"1.60"},{"groupId":"OG001","value":"6.51","spread":"1.50"}]}]},{"title":"Role Limitation Due to Physical (N=106, 116)","categories":[{"measurements":[{"groupId":"OG000","value":"11.73","spread":"3.17"},{"groupId":"OG001","value":"8.60","spread":"2.97"}]}]},{"title":"Pain (N=106, 116)","categories":[{"measurements":[{"groupId":"OG000","value":"12.42","spread":"1.72"},{"groupId":"OG001","value":"8.84","spread":"1.62"}]}]},{"title":"Sexual Function (N=106, 116)","categories":[{"measurements":[{"groupId":"OG000","value":"1.30","spread":"2.21"},{"groupId":"OG001","value":"1.12","spread":"2.09"}]}]},{"title":"Social Function (N=106, 116)","categories":[{"measurements":[{"groupId":"OG000","value":"5.02","spread":"1.71"},{"groupId":"OG001","value":"6.97","spread":"1.61"}]}]},{"title":"Health Distress (N=106, 116)","categories":[{"measurements":[{"groupId":"OG000","value":"8.96","spread":"1.76"},{"groupId":"OG001","value":"9.34","spread":"1.66"}]}]},{"title":"Overall Quality Of Life (N=106, 116)","categories":[{"measurements":[{"groupId":"OG000","value":"3.66","spread":"1.34"},{"groupId":"OG001","value":"5.43","spread":"1.26"}]}]},{"title":"Emotional Well-being Subsection Score (N=106, 116)","categories":[{"measurements":[{"groupId":"OG000","value":"4.59","spread":"1.37"},{"groupId":"OG001","value":"3.99","spread":"1.29"}]}]},{"title":"Role Limitation Due to Emotional (N=106, 116)","categories":[{"measurements":[{"groupId":"OG000","value":"6.48","spread":"3.55"},{"groupId":"OG001","value":"1.58","spread":"3.33"}]}]},{"title":"Cognitive Function (N=106, 116)","categories":[{"measurements":[{"groupId":"OG000","value":"6.38","spread":"1.45"},{"groupId":"OG001","value":"5.57","spread":"1.36"}]}]},{"title":"Change in Health (N=106, 116)","categories":[{"measurements":[{"groupId":"OG000","value":"8.23","spread":"2.30"},{"groupId":"OG001","value":"6.25","spread":"2.16"}]}]},{"title":"Satisfaction with Sexual Function (N=102, 112)","categories":[{"measurements":[{"groupId":"OG000","value":"2.66","spread":"2.82"},{"groupId":"OG001","value":"-1.35","spread":"2.68"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.500","pValueComment":"P-value is for treatment comparison of change from baseline on MSQOL Physical Health Composite Section score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"ANCOVA","statisticalComment":"Model: Change from Baseline = Treatment + Investigator + Baseline Value.","paramType":"Mean Difference (Final Values)","paramValue":"-1.00","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.90","ciUpperLimit":"1.91","estimateComment":"The mean difference is for placebo - duloxetine."},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.512","pValueComment":"P-value is for treatment comparison of change from baseline on MSQOL Mental Health Composite Section score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"ANCOVA","statisticalComment":"Model: Change from Baseline = Treatment + Investigator + Baseline Value.","paramType":"Mean Difference (Final Values)","paramValue":"-1.22","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.87","ciUpperLimit":"2.44","estimateComment":"The mean difference is for placebo - duloxetine."},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.720","pValueComment":"P-value is for treatment comparison of change from baseline on MSQOL Physical Health Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"ANCOVA","statisticalComment":"Model: Change from Baseline = Treatment + Investigator + Baseline Value.","paramType":"Mean Difference (Final Values)","paramValue":"-0.69","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.51","ciUpperLimit":"3.12","estimateComment":"The mean difference is for placebo - duloxetine."},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.973","pValueComment":"P-value is for treatment comparison of change from baseline on MSQOL Health Perceptions Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"ANCOVA","statisticalComment":"Model: Change from Baseline = Treatment + Investigator + Baseline Value.","paramType":"Mean Difference (Final Values)","paramValue":"-0.06","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.58","ciUpperLimit":"3.46","estimateComment":"The mean difference is for placebo - duloxetine."},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.991","pValueComment":"P-value is for treatment comparison of change from baseline on MSQOL Energy Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"ANCOVA","statisticalComment":"Model: Change from Baseline = Treatment + Investigator + Baseline Value.","paramType":"Mean Difference (Final Values)","paramValue":"-0.02","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.07","ciUpperLimit":"4.02","estimateComment":"The mean difference is for placebo - duloxetine."},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.441","pValueComment":"P-value is for treatment comparison of change from baseline on MSQOL Role Limitation Due to Physical Problems Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"ANCOVA","statisticalComment":"Model: Change from Baseline = Treatment + Investigator + Baseline Value.","paramType":"Mean Difference (Final Values)","paramValue":"-3.14","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-11.14","ciUpperLimit":"4.87","estimateComment":"The mean difference is for placebo - duloxetine."},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.108","pValueComment":"P-value is for treatment comparison of change from baseline on MSQOL Pain Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"ANCOVA","statisticalComment":"Model: Change from Baseline = Treatment + Investigator + Baseline Value.","paramType":"Mean Difference (Final Values)","paramValue":"-3.58","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-7.94","ciUpperLimit":"0.79","estimateComment":"The mean difference is for placebo - duloxetine."},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.948","pValueComment":"P-value is for treatment comparison of change from baseline on MSQOL Sexual Function Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"ANCOVA","statisticalComment":"Model: Change from Baseline = Treatment + Investigator + Baseline Value.","paramType":"Mean Difference (Final Values)","paramValue":"-0.19","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-5.77","ciUpperLimit":"5.39","estimateComment":"The mean difference is for placebo - duloxetine."},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.374","pValueComment":"P-value is for treatment comparison of change from baseline on MSQOL Social Function Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"ANCOVA","statisticalComment":"Model: Change from Baseline = Treatment + Investigator + Baseline Value.","paramType":"Mean Difference (Final Values)","paramValue":"1.96","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.37","ciUpperLimit":"6.28","estimateComment":"The mean difference is for placebo - duloxetine."},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.867","pValueComment":"P-value is for treatment comparison of change from baseline on MSQOL Health Distress Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"ANCOVA","statisticalComment":"Model: Change from Baseline = Treatment + Investigator + Baseline Value.","paramType":"Mean Difference (Final Values)","paramValue":"0.38","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.10","ciUpperLimit":"4.87","estimateComment":"The mean difference is for placebo - duloxetine."},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.306","pValueComment":"P-value is for treatment comparison of change from baseline on MSQOL Overall Quality Of Life Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"ANCOVA","statisticalComment":"Model: Change from Baseline = Treatment + Investigator + Baseline Value.","paramType":"Mean Difference (Final Values)","paramValue":"1.77","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.63","ciUpperLimit":"5.17","estimateComment":"The mean difference is for placebo - duloxetine."},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.733","pValueComment":"P-value is for treatment comparison of change from baseline on MSQOL Emotional Well-being Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"ANCOVA","statisticalComment":"Model: Change from Baseline = Treatment + Investigator + Baseline Value.","paramType":"Mean Difference (Final Values)","paramValue":"-0.60","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.08","ciUpperLimit":"2.88","estimateComment":"The mean difference is for placebo - duloxetine."},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.283","pValueComment":"P-value is for treatment comparison of change from baseline on MSQOL Role Limitation Due to Emotional Problems score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"ANCOVA","statisticalComment":"Model: Change from Baseline = Treatment + Investigator + Baseline Value.","paramType":"Mean Difference (Final Values)","paramValue":"-4.90","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-13.88","ciUpperLimit":"4.08","estimateComment":"The mean difference is for placebo - duloxetine."},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.664","pValueComment":"P-value is for treatment comparison of change from baseline on MSQOL Cognitive Function Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"ANCOVA","statisticalComment":"Model: Change from Baseline = Treatment + Investigator + Baseline Value.","paramType":"Mean Difference (Final Values)","paramValue":"-0.81","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.49","ciUpperLimit":"2.86","estimateComment":"The mean difference is for placebo - duloxetine."},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.504","pValueComment":"P-value is for treatment comparison of change from baseline on MSQOL Change in Health Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"ANCOVA","statisticalComment":"Model: Change from Baseline = Treatment + Investigator + Baseline Value.","paramType":"Mean Difference (Final Values)","paramValue":"-1.98","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-7.81","ciUpperLimit":"3.85","estimateComment":"The mean difference is for placebo - duloxetine"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.270","pValueComment":"P-value is for treatment comparison of change from baseline on MSQOL Satisfaction with Sexual Function Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"ANCOVA","statisticalComment":"Model: Change from Baseline = Treatment + Investigator + Baseline Value.","paramType":"Mean Difference (Final Values)","paramValue":"-4.02","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-11.18","ciUpperLimit":"3.14","estimateComment":"The mean difference is for placebo - duloxetine"}]},{"type":"SECONDARY","title":"Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 6","description":"C-SSRS scale captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a \"yes\" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a \"yes\" answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal act: a \"yes\" answer to actual attempt or completed suicide.","populationDescription":"All randomized participants.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"6 weeks","groups":[{"id":"OG000","title":"Duloxetine","description":"Participants received 30 milligrams (mg) duloxetine (oral \\[po\\], once daily \\[QD\\]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period."},{"id":"OG001","title":"Placebo","description":"Participants received placebo (po, QD) for 6 weeks (acute phase)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"118"},{"groupId":"OG001","value":"121"}]}],"classes":[{"title":"Suicidal Ideation","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"0"}]}]},{"title":"Suicidal Behavior","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}]},{"title":"Suicidal Acts","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.119","pValueComment":"P-value is for treatment comparison in number of participants with CSSR-S Suicidal Ideation during first 6 weeks of acute treatment. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"Fisher Exact","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.494","pValueComment":"P-value is for treatment comparison in number of participants with CSSR-S Suicidal Behavior during first 6 weeks of acute treatment. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"Fisher Exact","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.494","pValueComment":"P-value is for treatment comparison in number of participants with CSSR-S Suicidal Acts during first 6 weeks of acute treatment. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"Fisher Exact","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Change From Baseline in the Weekly Mean of Night Pain Scores at Week 6 (Acute Phase)","description":"Weekly mean of the night pain severity scores recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Participants should complete the electronic diary each day upon awakening. The Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity.","populationDescription":"Number of randomized participants with baseline and at least 1 post-baseline value.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on a scale","timeFrame":"Baseline, 6 weeks","groups":[{"id":"OG000","title":"Duloxetine","description":"Participants received 30 milligrams (mg) duloxetine (oral \\[po\\], once daily \\[QD\\]) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period."},{"id":"OG001","title":"Placebo","description":"Participants received placebo (po, QD) for 6 weeks (acute phase)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"115"},{"groupId":"OG001","value":"119"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.25","spread":"0.12"},{"groupId":"OG001","value":"-0.74","spread":"0.12"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.002","pValueComment":"P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed model repeated measures model:Change from Baseline=Baseline+Treatment+Investigator+Week+Treatment\\*Week+Baseline\\*Week; participant=random effect.","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Change From Baseline in the Beck Depression Inventory II (BDI-II) Question #9 at Week 6 (Acute Phase)","description":"The BDI-II is completed by the participant to rate the severity of depressive symptoms and any improvement during the course of the trial. The total score ranges from 0 to 63 with higher the score indicating more severe depressive symptoms. 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P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"t-test, 2 sided","statisticalComment":"One-sample t-test of mean change from extension phase baseline to endpoint on BPI-S for Worst Pain.","ciPctValue":"95"},{"groupIds":["OG000"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"The P-value is for BPI-S for Least Pain. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"t-test, 2 sided","statisticalComment":"One-sample t-test of mean change from extension phase baseline to endpoint on BPI-S for Least Pain score.","ciPctValue":"95"},{"groupIds":["OG000"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"The P-value is for BPI-S for Average Pain. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"t-test, 2 sided","statisticalComment":"One-sample t-test of mean change from extension phase baseline to endpoint on BPI-S for Average Pain score.","ciPctValue":"95"},{"groupIds":["OG000"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"t-test, 2 sided","statisticalComment":"One-sample t-test of mean change from extension phase baseline to endpoint on BPI-S for Pain Right Now score.","ciPctValue":"95"},{"groupIds":["OG000"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"The P-value is for BPI-I for General Activity. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"t-test, 2 sided","statisticalComment":"One-sample t-test of mean change from extension phase baseline to endpoint on BPI-I for General Activity score.","ciPctValue":"95"},{"groupIds":["OG000"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"The P-value is for the BPI-I for Mood. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"t-test, 2 sided","statisticalComment":"One-sample t-test of mean change from extension phase baseline to endpoint on BPI-I for Mood score.","ciPctValue":"95"},{"groupIds":["OG000"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"The P-value is for the BPI-I for Walking Ability. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"t-test, 2 sided","statisticalComment":"One-sample t-test of mean change from extension phase baseline to endpoint on BPI-I for Walking Ability score.","ciPctValue":"95"},{"groupIds":["OG000"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"The P-value is for the BPI-I for Normal Work. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"t-test, 2 sided","statisticalComment":"One-sample t-test of mean change from extension phase baseline to endpoint on BPI-I for Normal Work score.","ciPctValue":"95"},{"groupIds":["OG000"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"The P-value is for the BPI-I for Relations With Others. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"t-test, 2 sided","statisticalComment":"One-sample t-test of mean change from baseline to endpoint on BPI-I for Relations With Others score.","ciPctValue":"95"},{"groupIds":["OG000"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"The P-value is for the BPI-I for Sleep. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"t-test, 2 sided","statisticalComment":"One-sample t-test of mean change from extension phase baseline to endpoint on BPI-I for Sleep score.","ciPctValue":"95"},{"groupIds":["OG000"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"The P-value is for the BPI-I for Enjoyment of Life. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"t-test, 2 sided","statisticalComment":"One-sample t-test of mean change from extension phase baseline to endpoint on BPI-I for Enjoyment Of Life score.","ciPctValue":"95"},{"groupIds":["OG000"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"The P-value is for the BPI for Mean Interference Score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"t-test, 2 sided","statisticalComment":"One-sample t-test of mean change from extension phase baseline to endpoint on BPI for Mean Interference score.","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Change From Baseline in the Clinical Global Impression of Severity Scale (CGI-S) Score at Week 18 (Open-label Extension Phase)","description":"Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).","populationDescription":"Number of randomized participants who entered and had at least 1 non-missing value during extension phase.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Baseline (6 weeks), Endpoint (18 weeks)","groups":[{"id":"OG000","title":"Duloxetine","description":"All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"206"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.59","spread":"1.02"}]}]}],"analyses":[{"groupIds":["OG000"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"t-test, 2 sided","statisticalComment":"One-sample t-test of mean change from extension phase baseline to endpoint on CGI-S score for all participants who entered extension phase.","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Change From Baseline in Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at Week 18 (Open-label Extension Phase)","description":"A 54 question measure covers 12 domains; assesses mental and physical health. Each domain score is converted into a 0-100 score based on individual item responses; higher scores=better health status. The physical health composite score is a weighted average of the physical health scales, such as physical function, health perceptions, and energy. The mental health composite score is a weighted average of the mental health scales, such as overall quality of life, cognitive function, and health distress.","populationDescription":"Number of randomized participants who entered and had at least 1 non-missing value during extension phase.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Baseline (6 weeks), Endpoint (18 weeks)","groups":[{"id":"OG000","title":"Duloxetine","description":"All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"201"}]}],"classes":[{"title":"Physical Health Composite Section Score (N=198)","categories":[{"measurements":[{"groupId":"OG000","value":"2.70","spread":"12.32"}]}]},{"title":"Mental Health Composite Section Score (N=201)","categories":[{"measurements":[{"groupId":"OG000","value":"1.97","spread":"14.45"}]}]},{"title":"Physical Health Subsection Score (N=201)","categories":[{"measurements":[{"groupId":"OG000","value":"3.16","spread":"14.29"}]}]},{"title":"Health Perceptions Subsection Score (N=201)","categories":[{"measurements":[{"groupId":"OG000","value":"2.24","spread":"14.04"}]}]},{"title":"Energy Subsection Score (N=201)","categories":[{"measurements":[{"groupId":"OG000","value":"2.93","spread":"15.42"}]}]},{"title":"Role Limitation Due to Physical Problems (N=201)","categories":[{"measurements":[{"groupId":"OG000","value":"0.50","spread":"39.29"}]}]},{"title":"Pain Subsection Score (N=201)","categories":[{"measurements":[{"groupId":"OG000","value":"7.45","spread":"17.57"}]}]},{"title":"Sexual Function Subsection Score (N=198)","categories":[{"measurements":[{"groupId":"OG000","value":"0.79","spread":"23.38"}]}]},{"title":"Social Function Subsection Score (N=201)","categories":[{"measurements":[{"groupId":"OG000","value":"2.53","spread":"18.30"}]}]},{"title":"Health Distress Subsection Score (N=201)","categories":[{"measurements":[{"groupId":"OG000","value":"1.44","spread":"18.51"}]}]},{"title":"Overall Quality Of Life Subsection Score (N=201)","categories":[{"measurements":[{"groupId":"OG000","value":"1.47","spread":"11.04"}]}]},{"title":"Emotional Well-being Subsection Score (N=201)","categories":[{"measurements":[{"groupId":"OG000","value":"2.63","spread":"13.61"}]}]},{"title":"Role Limitation Due to Emotional Problems (N=201)","categories":[{"measurements":[{"groupId":"OG000","value":"3.15","spread":"38.96"}]}]},{"title":"Cognitive Function Subsection Score (N=201)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.07","spread":"14.64"}]}]},{"title":"Change in Health Subsection Score (N=201)","categories":[{"measurements":[{"groupId":"OG000","value":"4.35","spread":"25.30"}]}]},{"title":"Satisfaction with Sexual Function Subsect (N=195)","categories":[{"measurements":[{"groupId":"OG000","value":"1.92","spread":"30.56"}]}]}],"analyses":[{"groupIds":["OG000"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.002","pValueComment":"P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"t-test, 2 sided","statisticalComment":"One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Physical Health Composite Section score.","ciPctValue":"95"},{"groupIds":["OG000"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.054","pValueComment":"P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"t-test, 2 sided","statisticalComment":"One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Mental Health Composite Section score.","ciPctValue":"95"},{"groupIds":["OG000"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.002","pValueComment":"P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"t-test, 2 sided","statisticalComment":"One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Physical Health Subsection score.","ciPctValue":"95"},{"groupIds":["OG000"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.025","pValueComment":"P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"t-test, 2 sided","statisticalComment":"One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Health Perceptions Subsection score.","ciPctValue":"95"},{"groupIds":["OG000"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.008","pValueComment":"P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"t-test, 2 sided","statisticalComment":"One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Energy Subsection score.","ciPctValue":"95"},{"groupIds":["OG000"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.858","pValueComment":"P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"t-test, 2 sided","statisticalComment":"One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Role Limitation Due to Physical Problems Subsection score.","ciPctValue":"95"},{"groupIds":["OG000"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"t-test, 2 sided","statisticalComment":"One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Pain Subsection score.","ciPctValue":"95"},{"groupIds":["OG000"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.637","pValueComment":"P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"t-test, 2 sided","statisticalComment":"One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Sexual Function Subsection score.","ciPctValue":"95"},{"groupIds":["OG000"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.051","pValueComment":"P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"t-test, 2 sided","statisticalComment":"One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Social Function Subsection score.","ciPctValue":"95"},{"groupIds":["OG000"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.270","pValueComment":"P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"t-test, 2 sided","statisticalComment":"One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Health Distress Subsection score.","ciPctValue":"95"},{"groupIds":["OG000"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.061","pValueComment":"P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"t-test, 2 sided","statisticalComment":"One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Overall Quality Of Life Subsection score.","ciPctValue":"95"},{"groupIds":["OG000"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.007","pValueComment":"P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"t-test, 2 sided","statisticalComment":"One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Emotional Well-being Subsection score.","ciPctValue":"95"},{"groupIds":["OG000"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.253","pValueComment":"P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"t-test, 2 sided","statisticalComment":"One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Role Limitation Due to Emotional Problems score.","ciPctValue":"95"},{"groupIds":["OG000"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.942","pValueComment":"P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"t-test, 2 sided","statisticalComment":"One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Cognitive Function Subsection score.","ciPctValue":"95"},{"groupIds":["OG000"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.016","pValueComment":"P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"t-test, 2 sided","statisticalComment":"One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Change in Health Subsection score.","ciPctValue":"95"},{"groupIds":["OG000"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.381","pValueComment":"P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"t-test, 2 sided","statisticalComment":"One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Satisfaction with Sexual Function Subsection score.","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 18","description":"C-SSRS scale captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a \"yes\" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a \"yes\" answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal act: a \"yes\" answer to actual attempt or completed suicide.","populationDescription":"All randomized participants who entered the extension phase.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"18 weeks","groups":[{"id":"OG000","title":"Duloxetine","description":"All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"209"}]}],"classes":[{"title":"Suicidal Ideation","categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}]},{"title":"Suicidal Behavior","categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]},{"title":"Suicidal Acts","categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]}]},{"type":"SECONDARY","title":"Change in the Weekly Mean of the Night Pain Scores From Week 6 Through Week 18 (Open-label Extension Phase)","description":"Weekly mean of the night pain severity scores recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Participants should complete the electronic diary each day upon awakening. Each weekly mean change represents change relative to week 6, the baseline of the extension phase.","populationDescription":"Number of randomized participants who entered and had at least 1 non-missing value during extension phase.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on a scale","timeFrame":"Baseline (6 weeks) through Endpoint (18 weeks)","groups":[{"id":"OG000","title":"Duloxetine","description":"All participants randomized to placebo or duloxetine in the acute phase took duloxetine during extension phase: 60, 90, or 120 mg QD for 12 weeks (open-label extension phase)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"206"}]}],"classes":[{"title":"Week 7 (n=185)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.05","spread":"0.07"}]}]},{"title":"Week 8 (n=205)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.31","spread":"0.07"}]}]},{"title":"Week 9 (n=184)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.54","spread":"0.08"}]}]},{"title":"Week 10 (n=197)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.62","spread":"0.08"}]}]},{"title":"Week 11 (n=166)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.75","spread":"0.08"}]}]},{"title":"Week 12 (n=192)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.89","spread":"0.09"}]}]},{"title":"Week 13 (n=166)","categories":[{"measurements":[{"groupId":"OG000","value":"-1.05","spread":"0.09"}]}]},{"title":"Week 14 (n=177)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.98","spread":"0.10"}]}]},{"title":"Week 15 (n=158)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.99","spread":"0.11"}]}]},{"title":"Week 16 (n=176)","categories":[{"measurements":[{"groupId":"OG000","value":"-1.04","spread":"0.11"}]}]},{"title":"Week 17 (n=156)","categories":[{"measurements":[{"groupId":"OG000","value":"-1.11","spread":"0.11"}]}]},{"title":"Week 18 (n=175)","categories":[{"measurements":[{"groupId":"OG000","value":"-1.04","spread":"0.11"}]}]}],"analyses":[{"groupIds":["OG000"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.524","pValueComment":"P-value is for test of mean change from extension phase baseline to endpoint (Week 7). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed model repeated measures (MMRM) Model: Change from Baseline=Baseline+Investigator+Week+Baseline\\*Week; participant was treated as random effect.","ciPctValue":"95"},{"groupIds":["OG000"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"P-value is for test of mean change from extension phase baseline to endpoint (Week 8). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\\* Week, where participant was treated as a random effect.","ciPctValue":"95"},{"groupIds":["OG000"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"P-value is for test of mean change from extension phase baseline to endpoint (Week 9). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\\* Week, where participant was treated as a random effect.","ciPctValue":"95"},{"groupIds":["OG000"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"P-value is for test of mean change from extension phase baseline to endpoint (Week 10). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\\* Week, where participant was treated as a random effect.","ciPctValue":"95"},{"groupIds":["OG000"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"P-value is for test of mean change from extension phase baseline to endpoint (Week 11). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\\* Week, where participant was treated as a random effect.","ciPctValue":"95"},{"groupIds":["OG000"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"P-value is for test of mean change from extension phase baseline to endpoint (Week 12). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\\* Week, where participant was treated as a random effect.","ciPctValue":"95"},{"groupIds":["OG000"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"P-value is for test of mean change from extension phase baseline to endpoint (Week 13). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\\* Week, where participant was treated as a random effect.","ciPctValue":"95"},{"groupIds":["OG000"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"P-value is for test of mean change from extension phase baseline to endpoint (Week 14). P-values are not adjusted for multiple comparisons. 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