{"protocolSection":{"identificationModule":{"nctId":"NCT00408993","orgStudyIdInfo":{"id":"10599"},"secondaryIdInfos":[{"id":"F1J-MC-HMEQ(a)","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"Duloxetine Versus Placebo in the Treatment of Patients With Diabetic Peripheral Neuropathic Pain in China","officialTitle":"Duloxetine Versus Placebo in the Treatment of Patients With Diabetic Peripheral Neuropathic Pain in China"},"statusModule":{"statusVerifiedDate":"2011-07","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2006-12"},"primaryCompletionDateStruct":{"date":"2008-02","type":"ACTUAL"},"completionDateStruct":{"date":"2008-02","type":"ACTUAL"},"studyFirstSubmitDate":"2006-12-06","studyFirstSubmitQcDate":"2006-12-06","studyFirstPostDateStruct":{"date":"2006-12-08","type":"ESTIMATED"},"resultsFirstSubmitDate":"2009-02-05","resultsFirstSubmitQcDate":"2009-04-09","resultsFirstPostDateStruct":{"date":"2009-06-02","type":"ESTIMATED"},"lastUpdateSubmitDate":"2011-07-22","lastUpdatePostDateStruct":{"date":"2011-07-26","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"oldNameTitle":"Chief Medical Officer","oldOrganization":"Eli Lilly"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"},"collaborators":[{"name":"Boehringer Ingelheim","class":"INDUSTRY"}]},"descriptionModule":{"briefSummary":"To determine if duloxetine 60mg up to 120mg daily can work in treating pain from Diabetic Neuropathy."},"conditionsModule":{"conditions":["Diabetic Neuropathies"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":215,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Duloxetine","type":"EXPERIMENTAL","description":"60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)","interventionNames":["Drug: Duloxetine Hydrochloride"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Placebo every day (QD), by mouth (PO) for 12 weeks","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Duloxetine Hydrochloride","description":"60 mg every day (QD) (morning or evening), by mouth (PO)","armGroupLabels":["Duloxetine"],"otherNames":["LY248686","Cymbalta"]},{"type":"DRUG","name":"Placebo","description":"Placebo every day (QD), by mouth (PO)","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline to 12 Week Endpoint in Brief Pain Inventory 24-hour Average Pain Score","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).","timeFrame":"Baseline and 12 weeks"}],"secondaryOutcomes":[{"measure":"Change From Baseline to 12 Week Endpoint in Brief Pain Inventory (BPI) Worst Pain, Least Pain, and Current Pain Severity and Average Interference Scores","description":"Measures severity of pain and interference of pain on function. Each severity of pain (worst, least, and current) scores range from 0 (no pain) to 10 (pain as severe as you can imagine). The 7 separate Interference item scores range from 0 (does not interfere) to 10 (completely interferes) and were averaged to provide a single score (0 to 10).","timeFrame":"Baseline and 12 weeks"},{"measure":"Change From Baseline to 12 Week Endpoint in Clinical Global Impression of Severity","description":"Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.","timeFrame":"Baseline and 12 weeks"},{"measure":"Time Course of Change in Patient Global Impression - Improvement Scale","description":"A scale that measures the patient'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).","timeFrame":"baseline, over 12 weeks"},{"measure":"Change From Baseline to 12 Week Endpoint in EuroQoL Questionnaire - 5 Dimensions (EQ-5D) (US Based Index Score)","description":"The EQ-5D is an assessment of one's overall health. Consists of 5 items. Patients choose 1 of 3 options that best describe the status of each item. The EQ-5D US based index scores range from -0.11 to 1.0 where a score of 1.0 indicates perfect health. A positive change from baseline indicates health improvement.","timeFrame":"Baseline and 12 weeks"},{"measure":"Number of Participants Discontinuing Due to Adverse Events","timeFrame":"over 12 weeks"},{"measure":"Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening)","description":"Tolerability of morning versus evening dosing, as assessed by the number of participants with spontaneously reported adverse events.","timeFrame":"over 12 weeks"},{"measure":"Change From Baseline to 12 Week Endpoint in Athens Insomnia Scale 8-item and 5-item","description":"Estimates sleep difficulty. Consists of 8 items rated on a 4-point scale of 0 (no problem at all) to 3 (very serious problem). Total score of the 8-item version (sum of items 1-8) ranges from 0-24, while total score of the 5-item (sum of items 1-5) ranges from 0-15.","timeFrame":"Baseline and 12 weeks"},{"measure":"Vital Signs - Weight","description":"Change from baseline to endpoint in body weight.","timeFrame":"Baseline and 12 weeks"},{"measure":"Vital Signs - Pulse Rate","description":"Change from baseline to endpoint in pulse rate.","timeFrame":"Baseline and 12 weeks"},{"measure":"Vital Signs - Blood Pressure","description":"Change from baseline to endpoint in systolic and diastolic blood pressure.","timeFrame":"Baseline and 12 weeks"},{"measure":"Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Chloride, High Density Lipoprotein, Sodium, and Triglycerides","description":"Significantly different laboratory values between the two groups in baseline to endpoint changes in chloride, high density lipoprotein, sodium, and triglycerides.","timeFrame":"Baseline and 12 weeks"},{"measure":"Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Uric Acid","description":"Significantly different laboratory values between the two groups in baseline to endpoint changes","timeFrame":"Baseline and 12 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Have pain due to bilateral peripheral neuropathy caused by Type I or Type II diabetes with the pain beginning in the feet and present for at least 6 months.\n* May not be pregnant and agree to utilize medically acceptable and reliable means of birth control during participation in the study.\n* Score of 4 or greater on the Brief Pain Inventory on the 24-hour average pain item.\n\nExclusion Criteria:\n\n* Glycosylated hemoglobin (A1C) \\> 12%\n* Severe hepatic disease\n* History of substance abuse or dependence within the past year, excluding nicotine and caffeine.\n* Serious or unstable cardiovascular, hepatic (acute liver injury such as hepatitis or severe cirrhosis), kidney, respiratory, blood disorder, seizure disorder, problems with peripheral vascular disease, or other medical conditions or psychiatric conditions that would hinder your participation or likely to lead to hospitalization during the course of the study.\n* Taking monoamine oxidase inhibitor (MAOI) within 14 days of starting the study or the potential need to take during or within 5 days after discontinuation from the study.\n* Treatment of fluoxetine within 30 days of starting the study.\n* Unstable blood sugar control and uncontrolled or poorly controlled hypertension.","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 from 9AM - 5PM 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":"Beijing","zip":"100101","country":"China","geoPoint":{"lat":39.9075,"lon":116.39723}},{"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":"Changsha","zip":"410011","country":"China","geoPoint":{"lat":28.19874,"lon":112.97087}},{"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":"Harbin","zip":"150086","country":"China","geoPoint":{"lat":45.75,"lon":126.65}},{"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":"Nanjin","zip":"210012","country":"China","geoPoint":{"lat":29.98497,"lon":106.26529}},{"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":"Nanjing","zip":"210029","country":"China","geoPoint":{"lat":32.06167,"lon":118.77778}},{"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":"Shanghai","zip":"200233","country":"China","geoPoint":{"lat":31.22222,"lon":121.45806}},{"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":"Wuhan","zip":"430022","country":"China","geoPoint":{"lat":30.58333,"lon":114.26667}}]},"referencesModule":{"references":[{"pmid":"21163113","type":"RESULT","citation":"Gao Y, Ning G, Jia WP, Zhou ZG, Xu ZR, Liu ZM, Liu C, Ma JH, Li Q, Cheng LL, Wen CY, Zhang SY, Zhang Q, Desaiah D, Skljarevski V. Duloxetine versus placebo in the treatment of patients with diabetic neuropathic pain in China. Chin Med J (Engl). 2010 Nov;123(22):3184-92."}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Duloxetine","description":"60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)"},{"id":"FG001","title":"Placebo","description":"Placebo every day (QD), by mouth (PO) for 12 weeks"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"106"},{"groupId":"FG001","numSubjects":"109"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"87"},{"groupId":"FG001","numSubjects":"92"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"19"},{"groupId":"FG001","numSubjects":"17"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"15"},{"groupId":"FG001","numSubjects":"4"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"6"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"4"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"3"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Duloxetine","description":"60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)"},{"id":"BG001","title":"Placebo","description":"Placebo every day (QD), by mouth (PO) for 12 weeks"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"106"},{"groupId":"BG001","value":"109"},{"groupId":"BG002","value":"215"}]}],"measures":[{"title":"Age Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"58.59","spread":"10.37"},{"groupId":"BG001","value":"59.90","spread":"9.52"},{"groupId":"BG002","value":"59.25","spread":"9.94"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"55"},{"groupId":"BG001","value":"59"},{"groupId":"BG002","value":"114"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"51"},{"groupId":"BG001","value":"50"},{"groupId":"BG002","value":"101"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"China","categories":[{"measurements":[{"groupId":"BG000","value":"106"},{"groupId":"BG001","value":"109"},{"groupId":"BG002","value":"215"}]}]}]},{"title":"Major Depressive Disorder","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"No","categories":[{"measurements":[{"groupId":"BG000","value":"89"},{"groupId":"BG001","value":"88"},{"groupId":"BG002","value":"177"}]}]},{"title":"Yes","categories":[{"measurements":[{"groupId":"BG000","value":"17"},{"groupId":"BG001","value":"21"},{"groupId":"BG002","value":"38"}]}]}]},{"title":"Race/Ethnicity","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"East Asian","categories":[{"measurements":[{"groupId":"BG000","value":"106"},{"groupId":"BG001","value":"109"},{"groupId":"BG002","value":"215"}]}]}]},{"title":"Type of Diabetes Mellitus","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Type I Diabetes Mellitus","categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"5"}]}]},{"title":"Type II Diabetes Mellitus","categories":[{"measurements":[{"groupId":"BG000","value":"103"},{"groupId":"BG001","value":"107"},{"groupId":"BG002","value":"210"}]}]}]},{"title":"Beck Depression Inventory-II Total Score","description":"A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"15.97","spread":"10.66"},{"groupId":"BG001","value":"15.27","spread":"11.49"},{"groupId":"BG002","value":"15.61","spread":"11.07"}]}]}]},{"title":"Brief Pain Inventory 24-Hour Average Pain Score","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":"5.47","spread":"1.31"},{"groupId":"BG001","value":"5.52","spread":"1.39"},{"groupId":"BG002","value":"5.50","spread":"1.35"}]}]}]},{"title":"Clinical Global Impressions of Severity Score","description":"Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"4.26","spread":"0.76"},{"groupId":"BG001","value":"4.38","spread":"0.91"},{"groupId":"BG002","value":"4.32","spread":"0.84"}]}]}]},{"title":"Diabetic Neuropathy History","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"title":"Duration of Diabetes","categories":[{"measurements":[{"groupId":"BG000","value":"9.07","spread":"6.32"},{"groupId":"BG001","value":"10.21","spread":"6.91"},{"groupId":"BG002","value":"9.65","spread":"6.63"}]}]},{"title":"Duration of Diabetic Neuropathy","categories":[{"measurements":[{"groupId":"BG000","value":"2.13","spread":"2.60"},{"groupId":"BG001","value":"2.50","spread":"2.98"},{"groupId":"BG002","value":"2.32","spread":"2.80"}]}]},{"title":"Duration of Diabetic Peripheral Neuropathic Pain","categories":[{"measurements":[{"groupId":"BG000","value":"3.09","spread":"3.11"},{"groupId":"BG001","value":"3.34","spread":"3.36"},{"groupId":"BG002","value":"3.22","spread":"3.24"}]}]}]},{"title":"Height","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"centimeters","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"162.64","spread":"7.72"},{"groupId":"BG001","value":"162.12","spread":"7.96"},{"groupId":"BG002","value":"162.37","spread":"7.83"}]}]}]},{"title":"Michigan Neuropathy Screening Instrument","description":"Assesses degree of neuropathy. Responses to 13 out of 15 items are added to obtain total score. Responses of \"yes\" to items 1,2,3,5,6,8,9,11,12,14,15 are each counted as one point. A \"no\" response on items 7 and 13 counts as 1 point. Items 4 and 10 are not included in scoring. Total scores range from 0 (no neuropathy) to 13 (severe neuropathy).","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"4.45","spread":"1.19"},{"groupId":"BG001","value":"4.59","spread":"1.19"},{"groupId":"BG002","value":"4.52","spread":"1.19"}]}]}]},{"title":"Weight","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kilograms","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"64.06","spread":"10.62"},{"groupId":"BG001","value":"63.25","spread":"11.52"},{"groupId":"BG002","value":"63.65","spread":"11.07"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change From Baseline to 12 Week Endpoint in Brief Pain Inventory 24-hour Average Pain Score","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).","populationDescription":"Intention to Treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline value.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on a scale","timeFrame":"Baseline and 12 weeks","groups":[{"id":"OG000","title":"Duloxetine","description":"60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)"},{"id":"OG001","title":"Placebo","description":"Placebo every day (QD), by mouth (PO) for 12 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"104"},{"groupId":"OG001","value":"109"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.69","spread":"0.19"},{"groupId":"OG001","value":"-2.31","spread":"0.18"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"With 104 patients per arm, the study has at least 85% power to detect a treatment group difference of -1.20 points in baseline to endpoint mean change on the BPI 24-hour average pain score between Duloxetine and Placebo. Sample size determined using a two-sided t-test with alpha=0.05, and assuming a common standard deviation of 2.5 and a discontinuation rate of 25%.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.617","pValueComment":"Treatment effects were evaluated based on a two-sided significance level of 0.05 and interaction effects at 0.10. No adjustments for multiple comparisons were made.","statisticalMethod":"ANCOVA","statisticalComment":"Model=Treatment, Pooled Investigator and Baseline.","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Change From Baseline to 12 Week Endpoint in Brief Pain Inventory (BPI) Worst Pain, Least Pain, and Current Pain Severity and Average Interference Scores","description":"Measures severity of pain and interference of pain on function. Each severity of pain (worst, least, and current) scores range from 0 (no pain) to 10 (pain as severe as you can imagine). The 7 separate Interference item scores range from 0 (does not interfere) to 10 (completely interferes) and were averaged to provide a single score (0 to 10).","populationDescription":"Intention to Treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline value.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on a scale","timeFrame":"Baseline and 12 weeks","groups":[{"id":"OG000","title":"Duloxetine","description":"60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)"},{"id":"OG001","title":"Placebo","description":"Placebo every day (QD), by mouth (PO) for 12 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"104"},{"groupId":"OG001","value":"109"}]}],"classes":[{"title":"Worst Pain Score","categories":[{"measurements":[{"groupId":"OG000","value":"-3.48","spread":"0.27"},{"groupId":"OG001","value":"-2.93","spread":"0.26"}]}]},{"title":"Least Pain Score","categories":[{"measurements":[{"groupId":"OG000","value":"-1.69","spread":"0.20"},{"groupId":"OG001","value":"-1.37","spread":"0.20"}]}]},{"title":"Pain Right Now Score","categories":[{"measurements":[{"groupId":"OG000","value":"-2.72","spread":"0.26"},{"groupId":"OG001","value":"-1.99","spread":"0.25"}]}]},{"title":"Average Interference Score","categories":[{"measurements":[{"groupId":"OG000","value":"-2.28","spread":"0.21"},{"groupId":"OG001","value":"-1.88","spread":"0.20"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.070","pValueComment":"P-value for Worst Pain Score","statisticalMethod":"ANCOVA","statisticalComment":"Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.151","pValueComment":"P-value for Least Pain Score","statisticalMethod":"ANCOVA","statisticalComment":"Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.012","pValueComment":"P-value for Pain Right Now Score","statisticalMethod":"ANCOVA","statisticalComment":"Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.077","pValueComment":"P-value for Average Interference Score","statisticalMethod":"ANCOVA","statisticalComment":"Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Change From Baseline to 12 Week Endpoint in Clinical Global Impression of Severity","description":"Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.","populationDescription":"Intention to Treat analysis. 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