{"protocolSection":{"identificationModule":{"nctId":"NCT01089556","orgStudyIdInfo":{"id":"13084"},"secondaryIdInfos":[{"id":"F1J-EW-HMGQ","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study in Painful Diabetic Neuropathy","officialTitle":"Use of Duloxetine or Pregabalin in Monotherapy Versus Combination Therapy of Both Drugs in Patients With Painful Diabetic Neuropathy \"The COMBO - DN (COmbination vs Monotherapy of pregaBalin and dulOxetine in Diabetic Neuropathy) Study\"","acronym":"COMBO-DN"},"statusModule":{"statusVerifiedDate":"2013-01","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2010-03"},"primaryCompletionDateStruct":{"date":"2011-11","type":"ACTUAL"},"completionDateStruct":{"date":"2011-11","type":"ACTUAL"},"studyFirstSubmitDate":"2010-03-15","studyFirstSubmitQcDate":"2010-03-17","studyFirstPostDateStruct":{"date":"2010-03-18","type":"ESTIMATED"},"resultsFirstSubmitDate":"2012-10-30","resultsFirstSubmitQcDate":"2012-10-30","resultsFirstPostDateStruct":{"date":"2012-12-04","type":"ESTIMATED"},"lastUpdateSubmitDate":"2013-01-17","lastUpdatePostDateStruct":{"date":"2013-01-24","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"},"collaborators":[{"name":"Boehringer Ingelheim","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"This study will investigate the efficacy of a combination treatment of duloxetine + pregabalin compared with the maximal dose of each drug in monotherapy, in patients with diabetic peripheral neuropathic pain (DPNP) who have not responded to the standard recommended dose of either drug. It will provide an answer to a common clinical question, namely, is it better to increase the dose of the current monotherapy or to combine both treatments early on, in patients who do not respond to standard doses of duloxetine or pregabalin."},"conditionsModule":{"conditions":["Diabetic Neuropathy, Painful"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":811,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Duloxetine","type":"EXPERIMENTAL","description":"Initial Treatment:\n\nDuloxetine 30 milligram (mg) daily for 1 week\n\nDuloxetine 60 mg daily for 7 weeks\n\nIntensive Treatment:\n\nDuloxetine 90 mg (60 mg in the morning, 30 mg in the evening) daily for 1 week\n\nDuloxetine 120 mg (60 mg twice daily) daily for 7 weeks","interventionNames":["Drug: Duloxetine","Drug: Placebo"]},{"label":"Pregabalin+Duloxetine","type":"EXPERIMENTAL","description":"Initial Treatment:\n\nPregabalin 150 mg daily for 1 week\n\nPregabalin 300 mg (150 mg twice daily) daily for 7 weeks\n\nIntensive Treatment:\n\nPregabalin 300 mg (150 mg twice daily) daily for 8 weeks\n\nDuloxetine 30 mg daily for 1 week\n\nDuloxetine 60 mg daily for 7 weeks","interventionNames":["Drug: Duloxetine","Drug: Pregabalin","Drug: Placebo"]},{"label":"Pregabalin","type":"EXPERIMENTAL","description":"Initial Treatment:\n\nPregabalin 150 mg daily for 1 week\n\nPregabalin 300 mg (150 mg twice daily) daily for 7 weeks\n\nIntensive Treatment:\n\nPregabalin 450 mg (300 mg in the morning, 150 mg in the evening) daily for 1 week\n\nPregabalin 600 mg (300 mg twice daily) daily for 7 weeks","interventionNames":["Drug: Pregabalin","Drug: Placebo"]},{"label":"Duloxetine + Pregabalin","type":"EXPERIMENTAL","description":"Initial Treatment:\n\nDuloxetine 30 mg daily for 1 week\n\nDuloxetine 60 mg daily for 7 weeks\n\nIntensive Treatment:\n\nDuloxetine 60 mg daily for 8 weeks\n\nPregabalin 150 mg daily for 1 week\n\nPregabalin 300 mg (150 mg twice daily) daily for 7 weeks","interventionNames":["Drug: Duloxetine","Drug: Pregabalin","Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Duloxetine","description":"Administered orally","armGroupLabels":["Duloxetine","Duloxetine + Pregabalin","Pregabalin+Duloxetine"],"otherNames":["Cymbalta","LY248686"]},{"type":"DRUG","name":"Pregabalin","description":"Administered orally","armGroupLabels":["Duloxetine + Pregabalin","Pregabalin","Pregabalin+Duloxetine"]},{"type":"DRUG","name":"Placebo","description":"Administered orally, daily as a blind for duloxetine and/or pregabalin for 8 or 16 weeks","armGroupLabels":["Duloxetine","Duloxetine + Pregabalin","Pregabalin","Pregabalin+Duloxetine"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Week 8 to Week 16 Endpoint in 24 Hour Average Pain Item Score on the Brief Pain Inventory (BPI) Modified Short Form","description":"BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment\\*visit, baseline\\*visit and treatment in Study Period II.","timeFrame":"Week 8, Week 16"}],"secondaryOutcomes":[{"measure":"Mean Change From Week 8 to Week 16 Endpoint in Items of the Brief Pain Inventory (BPI) Modified Short Form Worst Pain Score","description":"BPI Modified Short Form worst pain score is a self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment\\*visit, baseline\\*visit and treatment in Study Period II.","timeFrame":"Week 8, Week 16"},{"measure":"Percentage of Participants With a Reduction of Greater Than or Equal to 30% on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 16 Endpoint","description":"BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).","timeFrame":"Week 8 through Week 16"},{"measure":"Percentage of Participants With a Reduction of Greater Than or Equal to 50% on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 16 Endpoint","description":"BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).","timeFrame":"Week 8 through Week 16"},{"measure":"Percentage of Participants With a Decrease of Greater Than or Equal to 2 Points on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 16 Endpoint","description":"BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).","timeFrame":"Week 8 through Week 16"},{"measure":"Clinical Global Impression of Improvement (CGI-I) at Week 16 Endpoint","description":"Measures clinician's perception of participant improvement at the time of assessment compared with the start of treatment for Study Period III. Scores range from 1 (very much better) to 7 (very much worse). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment\\*visit, baseline\\*visit and treatment in Study Period II.","timeFrame":"Week 16"},{"measure":"Mean Change From Week 8 to Week 16 Endpoint on the Neuropathic Pain Symptom Inventory (NPSI) Questionnaire","description":"The NPSI is a 12-item self-administered questionnaire to assess 5 different dimensions of neuropathic pain: superficial spontaneous burning pain, deep spontaneous pressing pain, paroxysmal pain, evoked pains, and paresthesias/dysesthesias. A total score ranges from 0 to 100. Higher score indicates a greater intensity of pain. Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment\\*visit, baseline\\*visit and treatment in Study Period II.","timeFrame":"Week 8, Week 16"},{"measure":"Mean Change From Week 8 to Week 16 Endpoint in Sheehan Disability Scale (SDS)","description":"The SDS is completed by the participant and is used to assess the effect of the participant's symptoms on their work (Item 1), social (Item 2), and family life (Item 3). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Total scores is the sum of the 3 items and range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. Least Squares (LS) Mean values are controlled for treatment, site, baseline value, treatment\\*site and treatment in Study Period II.","timeFrame":"Week 8, Week 16"},{"measure":"Mean Change From Week 8 to Week 16 Endpoint in Hospital Anxiety and Depression Scale (HADS)","description":"A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale (0-3), giving maximum scores of 21 for anxiety and for depression. Scores of 11 or more on either subscale are considered to be a significant case of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7 represent 'normal.' Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment\\*visit, baseline\\*visit and treatment in Study Period II.","timeFrame":"Week 8, Week 16"},{"measure":"Resource Utilization (Number of Days Hospitalized, Number of Days of Sick Leave) Week 8 Through Week 16","description":"Data presented are the number of days hospitalized and work/school missed (sick leave) due to diabetic peripheral neuropathic pain (DPNP) during the last 8 weeks.","timeFrame":"Week 8 through Week 16"},{"measure":"Patient Global Impression of Improvement (PGI-I) Score at Week 16 Endpoint","description":"Measures participant's perception of improvement at the time of assessment compared with the start of treatment for Study Period III. The score ranges from 1 (very much better) to 7 (very much worse). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment\\*visit, baseline\\*visit and treatment in Study Period II.","timeFrame":"Week 16"},{"measure":"Mean Change in Blood Pressure (BP) From Week 8 to Week 16 Endpoint","description":"Least Squares (LS) mean values are controlled for treatment, site, baseline value, treatment\\*site and treatment in Study Period II.","timeFrame":"Week 8, Week 16"},{"measure":"Mean Change in Heart Rate From Week 8 to Week 16 Endpoint","description":"Least Squares (LS) mean values are controlled for treatment, site, baseline value, treatment\\*site and treatment in Study Period II.","timeFrame":"Week 8, Week 16"},{"measure":"Number of Participants With Treatment Emergent Adverse Events (TEAEs) Between Week 8 and Week 16 Endpoint","description":"TEAEs in Study Period III are events that began or worsened after Week 8 compared with the period before Week 8.","timeFrame":"Week 8 through Week 16"},{"measure":"Number of Participants Who Discontinued From Study Between Week 8 and Week 16 Endpoint","timeFrame":"Week 8 through Week 16"}],"otherOutcomes":[{"measure":"Mean Change From Baseline to Week 8 Endpoint in 24 Hour Average Pain Item Score on the Brief Pain Inventory (BPI) Modified Short Form","description":"BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment\\*visit and baseline\\*visit.","timeFrame":"Baseline, Week 8"},{"measure":"Percentage of Participants With a Reduction of Greater Than or Equal to 30% on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 8 Endpoint","description":"BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).","timeFrame":"Baseline through Week 8"},{"measure":"Percentage of Participants With a Reduction of Greater Than or Equal to 50% on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 8 Endpoint","description":"BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).","timeFrame":"Baseline through Week 8"},{"measure":"Percentage of Participants With a Decrease of Greater Than or Equal to 2 Points on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 8 Endpoint","description":"BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).","timeFrame":"Baseline through Week 8"},{"measure":"Clinical Global Impression of Improvement (CGI-I) at Week 8 Endpoint","description":"Measures clinician's perception of participant improvement at the time of assessment compared with the start of treatment. Scores range from 1 (very much better) to 7 (very much worse). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, visit, and treatment\\*visit.","timeFrame":"Week 8"},{"measure":"Mean Change From Baseline to Week 8 Endpoint on the Neuropathic Pain Symptom Inventory (NPSI) Questionnaire","description":"The NPSI is a 12-item self-administered questionnaire to assess 5 different dimensions of neuropathic pain: superficial spontaneous burning pain, deep spontaneous pressing pain, paroxysmal pain, evoked pains, and paresthesias/dysesthesias. A total score ranges from 0 to 100. Higher score indicates a greater intensity of pain. Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment\\*visit and baseline\\*visit.","timeFrame":"Baseline, Week 8"},{"measure":"Mean Change From Baseline to Week 8 Endpoint in Sheehan Disability Scale (SDS)","description":"The SDS is completed by the participant and is used to assess the effect of the participant's symptoms on their work (Item 1), social (Item 2), and family life (Item 3). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Total scores is the sum of the 3 items and range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. Least Squares (LS) mean values are controlled for treatment, site, baseline value and treatment\\*site.","timeFrame":"Baseline, Week 8"},{"measure":"Mean Change From Baseline to Week 8 Endpoint in Hospital Anxiety and Depression Scale (HADS)","description":"A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale (0-3), giving maximum scores of 21 for anxiety and for depression. Scores of 11 or more on either subscale are considered to be a significant case of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7 represent 'normal.' Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment\\*visit and baseline\\*visit.","timeFrame":"Baseline, Week 8"},{"measure":"Resource Utilization (Number of Days Hospitalized, Number of Days of Sick Leave) Baseline Through Week 8","description":"Data presented are the number of days hospitalized and work/school missed (sick leave) due to diabetic peripheral neuropathic pain (DPNP) during the last 8 weeks.","timeFrame":"Baseline through Week 8"},{"measure":"Average Number of Hours Worked for Pay Per Week Baseline Through Week 8","description":"Data presented are the average number of hours worked for pay per week during the last 8 weeks.","timeFrame":"Baseline through Week 8"},{"measure":"Average Number of Hours Worked for Pay Per Week Week 8 Through Week 16","description":"Data presented are the average number of hours worked for pay per week during the last 8 weeks.","timeFrame":"Week 8 through Week 16"},{"measure":"Patient Global Impression of Improvement (PGI-I) Score at Week 8 Endpoint","description":"Measures 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). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, visit, and treatment\\*visit.","timeFrame":"Week 8"},{"measure":"Mean Change in Blood Pressure (BP) From Baseline to Week 8 Endpoint","description":"Least Squares (LS) mean values are controlled for treatment, site, baseline value, and treatment\\*site.","timeFrame":"Baseline, Week 8"},{"measure":"Mean Change in Heart Rate From Baseline to Week 8 Endpoint","description":"Least Squares (LS) mean values are controlled for treatment, site, baseline value, and treatment\\*site.","timeFrame":"Baseline, Week 8"},{"measure":"Number of Participants With Treatment Emergent Adverse Events (TEAE) Between Baseline and Week 8 Endpoint","description":"TEAEs in Study Period II are events that began or worsened after Week 0 compared with the period before Week 0.","timeFrame":"Baseline through Week 8"},{"measure":"Number of Participants Who Discontinued From Study Between Baseline and Week 8 Endpoint","timeFrame":"Baseline through Week 8"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Pain due to bilateral peripheral neuropathy (caused by type 1 or type 2 diabetes mellitus. Pain must begin in the feet, with relatively symmetrical onset. Daily pain should be present for more than 3 months \\[assessed by questioning patient\\]).\n* Score of at least 4 on the 24-hour average pain severity score on an 11-point Likert scale \\[on Brief Pain Inventory (BPI) Modified Short Form\\] at screening and at randomization.\n* Patient is currently not receiving treatment for diabetic peripheral neuropathic pain (DPNP) or was receiving treatment for DPNP, with a drug other than pregabalin or duloxetine, and completed the required washout\n* Patient has never received treatment with duloxetine or pregabalin. (However, a short course of less than 15 days of treatment, at any time previously, will be allowed.)\n* Stable glycemic control, as assessed by a physician investigator, and hemoglobin A1c (HbA1c) less than or equal to 12% at screening.\n\nExclusion Criteria:\n\n* Have a known hypersensitivity to duloxetine or pregabalin or any of the inactive ingredients or have any contraindication for the use of duloxetine or pregabalin.\n* Have uncontrolled narrow-angle glaucoma.\n* Have received treatment with a monoamine oxidase inhibitor (MAOI) within 14 days prior to randomization, or have a potential need to use a MAOI during the study or within 5 days after discontinuation of study drug.\n* Have received fluoxetine within 30 days prior to randomization.\n* Have acute liver injury (such as hepatitis) or severe cirrhosis (Child-Pugh Class C).\n* Have a serum creatinine greater than or equal to 1.5 milligram per deciliter (mg/dL) or a creatinine clearance less than 60 milliliter per minute (mL/min), at screening.\n* Are judged clinically by the investigator to be at suicidal risk or as defined by a score of 2 or greater on Question 9 of the Beck Depression Inventory-II (BDI-II), at screening or randomization\n* Have a historical exposure to drugs known to cause neuropathy (for example, vincristine), or a history of a medical condition, including pernicious anemia and hypothyroidism, that could have been responsible for neuropathy.\n* Have pain that cannot be clearly differentiated from or conditions that interfere with the assessment of the DPNP.\n* Have serious or unstable cardiovascular, hepatic, renal, respiratory or hematological illness; symptomatic peripheral vascular disease; a history of seizure disorder; or other medical (including unstable hypertension and not clinically euthyroid) or psychological conditions that, in the opinion of the investigator, would compromise participation or be likely to require hospitalization during the course of the study.\n* Have received non-pharmacological treatment for pain within 14 days prior to randomization, or do not agree to abstain from non-pharmacological treatment during the study.\n* Have a history of frequent and/or severe allergic reactions with multiple medications.","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 - 5AM 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":"Newcastle","state":"New South Wales","zip":"2292","country":"Australia","geoPoint":{"lat":-32.92953,"lon":151.7801}},{"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":"Warrawong","state":"New South Wales","zip":"2502","country":"Australia","geoPoint":{"lat":-34.485,"lon":150.88833}},{"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":"Elizabeth Vale","state":"South Australia","zip":"5112","country":"Australia","geoPoint":{"lat":-34.74857,"lon":138.66819}},{"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":"Kelowna","state":"British Columbia","zip":"V1Y 1Z9","country":"Canada","geoPoint":{"lat":49.88307,"lon":-119.48568}},{"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":"Vancouver","state":"British Columbia","zip":"V6H 3X8","country":"Canada","geoPoint":{"lat":49.24966,"lon":-123.11934}},{"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":"R3P 3P4","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":"Halifax","state":"Nova Scotia","zip":"B3H 3A7","country":"Canada","geoPoint":{"lat":44.64269,"lon":-63.57688}},{"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":"Cambridge","state":"Ontario","zip":"N1R 7L6","country":"Canada","geoPoint":{"lat":43.3601,"lon":-80.31269}},{"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":"Laval","state":"Quebec","zip":"H7T 2P5","country":"Canada","geoPoint":{"lat":45.56995,"lon":-73.692}},{"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":"Osijek","zip":"31000","country":"Croatia","geoPoint":{"lat":45.55066,"lon":18.6942}},{"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":"Rijeka","zip":"HR-51000","country":"Croatia","geoPoint":{"lat":45.32673,"lon":14.44241}},{"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":"Varaždin","zip":"42000","country":"Croatia","geoPoint":{"lat":46.30444,"lon":16.33778}},{"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":"Zagreb","zip":"10000","country":"Croatia","geoPoint":{"lat":45.81444,"lon":15.97798}},{"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":"Angers","zip":"49933","country":"France","geoPoint":{"lat":47.47156,"lon":-0.55202}},{"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":"Bourges","zip":"18000","country":"France","geoPoint":{"lat":47.08333,"lon":2.4}},{"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":"Juan-les-Pins","zip":"06600","country":"France","geoPoint":{"lat":43.56945,"lon":7.11309}},{"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":"Nevers","zip":"58000","country":"France","geoPoint":{"lat":46.98956,"lon":3.159}},{"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":"Nîmes","zip":"30029","country":"France","geoPoint":{"lat":43.83665,"lon":4.35788}},{"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":"Paris","zip":"75018","country":"France","geoPoint":{"lat":48.85341,"lon":2.3488}},{"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":"Valenciennes","zip":"59322","country":"France","geoPoint":{"lat":50.35909,"lon":3.52506}},{"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":"Vierzon","zip":"18100","country":"France","geoPoint":{"lat":47.22186,"lon":2.0684}},{"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":"Vieux-Condé","zip":"59690","country":"France","geoPoint":{"lat":50.45944,"lon":3.56738}},{"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":"Dresden","zip":"01307","country":"Germany","geoPoint":{"lat":51.05089,"lon":13.73832}},{"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":"Schkeuditz","zip":"04435","country":"Germany","geoPoint":{"lat":51.39678,"lon":12.22141}},{"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":"Ampelokipoi","zip":"11527","country":"Greece","geoPoint":{"lat":37.75809,"lon":20.87248}},{"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":"Athens","zip":"11521","country":"Greece","geoPoint":{"lat":37.98376,"lon":23.72784}},{"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":"Melíssia","zip":"15126","country":"Greece","geoPoint":{"lat":38.05,"lon":23.83333}},{"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":"Catania","zip":"95100","country":"Italy","geoPoint":{"lat":37.49223,"lon":15.07041}},{"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":"Milan","zip":"20162","country":"Italy","geoPoint":{"lat":42.78235,"lon":12.59836}},{"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":"Naples","zip":"80131","country":"Italy","geoPoint":{"lat":40.85216,"lon":14.26811}},{"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":"Rome","zip":"00161","country":"Italy","geoPoint":{"lat":41.89193,"lon":12.51133}},{"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":"Mexico City","zip":"38000","country":"Mexico","geoPoint":{"lat":19.42847,"lon":-99.12766}},{"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":"Eindhoven","zip":"5623 EJ","country":"Netherlands","geoPoint":{"lat":51.44083,"lon":5.47778}},{"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":"Maastricht","zip":"6229 HX","country":"Netherlands","geoPoint":{"lat":50.84833,"lon":5.68889}},{"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":"Bialystok","zip":"15-445","country":"Poland","geoPoint":{"lat":53.13333,"lon":23.16433}},{"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":"20-538","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":"70-506","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":"50-127","country":"Poland","geoPoint":{"lat":51.10286,"lon":17.03006}},{"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":"Seoul","zip":"138-736","country":"South Korea","geoPoint":{"lat":37.566,"lon":126.9784}},{"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":"Girona","zip":"17007","country":"Spain","geoPoint":{"lat":41.98311,"lon":2.82493}},{"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":"Valencia","zip":"46010","country":"Spain","geoPoint":{"lat":39.47391,"lon":-0.37966}},{"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":"Falköping","zip":"SE 52143","country":"Sweden","geoPoint":{"lat":58.17347,"lon":13.55068}},{"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":"Huddinge","zip":"SE 141 86","country":"Sweden","geoPoint":{"lat":59.23705,"lon":17.98192}},{"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":"Lund","zip":"22185","country":"Sweden","geoPoint":{"lat":55.70584,"lon":13.19321}},{"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":"Stockholm","zip":"11522","country":"Sweden","geoPoint":{"lat":59.32938,"lon":18.06871}},{"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":"Zurich","zip":"CH-8091","country":"Switzerland","geoPoint":{"lat":47.36667,"lon":8.55}},{"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":"Ankara","zip":"06100","country":"Turkey (Türkiye)","geoPoint":{"lat":39.91987,"lon":32.85427}},{"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":"Izmir","zip":"35340","country":"Turkey (Türkiye)","geoPoint":{"lat":38.41273,"lon":27.13838}},{"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":"Ashton-under-Lyne","state":"Ashton-Under-Lyne","zip":"OL6 9RW","country":"United Kingdom","geoPoint":{"lat":53.48876,"lon":-2.0989}},{"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":"Chorley","state":"Chorley","zip":"PR7 1PP","country":"United Kingdom","geoPoint":{"lat":53.65,"lon":-2.61667}},{"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":"Manchester","state":"Greater Manchester","zip":"M13 0JE","country":"United Kingdom","geoPoint":{"lat":53.48095,"lon":-2.23743}},{"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":"Ayrshire","state":"Scotland","zip":"KA6 6DX","country":"United Kingdom"},{"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":"Nuneaton","state":"Warwickshire","zip":"CV10 7BL","country":"United Kingdom","geoPoint":{"lat":52.52323,"lon":-1.46523}},{"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":"Livingston","state":"West Lothian","zip":"EH54 6PP","country":"United Kingdom","geoPoint":{"lat":55.90288,"lon":-3.52261}}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"The study consisted of 4 study periods (SP): 2 weeks screening and washout (SP I), 8 weeks initial treatment (SP II), 8 weeks intensive treatment (SP III), 2 weeks tapering (SP IV). 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Violation","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"1"},{"groupId":"FG005","numSubjects":"0"}]},{"type":"Satisfactory Response","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"4"},{"groupId":"FG003","numSubjects":"3"},{"groupId":"FG004","numSubjects":"4"},{"groupId":"FG005","numSubjects":"1"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"1"},{"groupId":"FG005","numSubjects":"2"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Duloxetine","description":"Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period 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Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"182"},{"groupId":"BG001","value":"174"},{"groupId":"BG002","value":"356"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"219"},{"groupId":"BG001","value":"229"},{"groupId":"BG002","value":"448"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"37"},{"groupId":"BG001","value":"36"},{"groupId":"BG002","value":"73"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"34"},{"groupId":"BG001","value":"34"},{"groupId":"BG002","value":"68"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"}]},{"title":"Black or African 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Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Greece","categories":[{"measurements":[{"groupId":"BG000","value":"16"},{"groupId":"BG001","value":"12"},{"groupId":"BG002","value":"28"}]}]},{"title":"Spain","categories":[{"measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"14"}]}]},{"title":"Turkey","categories":[{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"12"}]}]},{"title":"United Kingdom","categories":[{"measurements":[{"groupId":"BG000","value":"31"},{"groupId":"BG001","value":"31"},{"groupId":"BG002","value":"62"}]}]},{"title":"Italy","categories":[{"measurements":[{"groupId":"BG000","value":"16"},{"groupId":"BG001","value":"18"},{"groupId":"BG002","value":"34"}]}]},{"title":"France","categories":[{"measurements":[{"groupId":"BG000","value":"22"},{"groupId":"BG001","value":"24"},{"groupId":"BG002","value":"46"}]}]},{"title":"Mexico","categories":[{"measurements":[{"groupId":"BG000","value":"75"},{"groupId":"BG001","value":"71"},{"groupId":"BG002","value":"146"}]}]},{"title":"Canada","categories":[{"measurements":[{"groupId":"BG000","value":"19"},{"groupId":"BG001","value":"19"},{"groupId":"BG002","value":"38"}]}]},{"title":"Poland","categories":[{"measurements":[{"groupId":"BG000","value":"56"},{"groupId":"BG001","value":"57"},{"groupId":"BG002","value":"113"}]}]},{"title":"Croatia","categories":[{"measurements":[{"groupId":"BG000","value":"27"},{"groupId":"BG001","value":"29"},{"groupId":"BG002","value":"56"}]}]},{"title":"Australia","categories":[{"measurements":[{"groupId":"BG000","value":"27"},{"groupId":"BG001","value":"22"},{"groupId":"BG002","value":"49"}]}]},{"title":"Netherlands","categories":[{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"9"}]}]},{"title":"Germany","categories":[{"measurements":[{"groupId":"BG000","value":"52"},{"groupId":"BG001","value":"54"},{"groupId":"BG002","value":"106"}]}]},{"title":"Korea, Republic of","categories":[{"measurements":[{"groupId":"BG000","value":"31"},{"groupId":"BG001","value":"32"},{"groupId":"BG002","value":"63"}]}]},{"title":"Sweden","categories":[{"measurements":[{"groupId":"BG000","value":"13"},{"groupId":"BG001","value":"15"},{"groupId":"BG002","value":"28"}]}]}]},{"title":"Clinical Global Impressions of Severity Scale (CGI-S)","description":"The clinician recorded how ill the participant was at the time of assessment, in relation to the clinician's total experience with this participant population. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). One participant in Duloxetine group and 2 participants in Pregabalin group had missing data and were not included in the calculation of mean and standard deviation (SD).","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"4.0","spread":"1.07"},{"groupId":"BG001","value":"4.0","spread":"1.09"},{"groupId":"BG002","value":"4.0","spread":"1.08"}]}]}]},{"title":"Patient Global Impressions of Severity Scale (PGI-S)","description":"Measures participant's perception of severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (extremely ill).","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"3.4","spread":"1.42"},{"groupId":"BG001","value":"3.4","spread":"1.41"},{"groupId":"BG002","value":"3.4","spread":"1.42"}]}]}]},{"title":"Brief Pain Inventory (BPI) Severity: Average Pain Score","description":"A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Two participants in Pregabalin group had missing data and were not included in the calculation of mean and SD.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"6.0","spread":"1.55"},{"groupId":"BG001","value":"6.0","spread":"1.57"},{"groupId":"BG002","value":"6.0","spread":"1.56"}]}]}]},{"title":"Neuropathic Pain Symptom Inventory (NPSI)","description":"The NPSI is a 12-item self-administered questionnaire to assess 5 different dimensions of neuropathic pain: superficial spontaneous burning pain, deep spontaneous pressing pain, paroxysmal pain, evoked pains, and paresthesias/dysesthesias. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain. Two participants in Duloxetine group and 6 participants in Pregabalin group had missing data and were not included in the calculation of mean and SD.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"47.3","spread":"19.16"},{"groupId":"BG001","value":"47.7","spread":"20.46"},{"groupId":"BG002","value":"47.5","spread":"19.81"}]}]}]},{"title":"Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale Score","description":"A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale (0-3), giving maximum scores of 21 for anxiety and for depression. Scores of 11 or more on either subscale are considered to be a significant case of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.' Three participants in both Duloxetine group and Pregabalin group had missing data and were not included in the calculation of mean and SD.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"6.8","spread":"4.31"},{"groupId":"BG001","value":"6.6","spread":"4.32"},{"groupId":"BG002","value":"6.7","spread":"4.31"}]}]}]},{"title":"Hospital Anxiety and Depression Scale (HADS) - Depression Subscale Score","description":"A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale (0-3), giving maximum scores of 21 for anxiety and for depression. Scores of 11 or more on either subscale are considered to be a significant case of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.' Two participants in Duloxetine group and 1 participant in Pregabalin group had missing data and were not included in the calculation of mean and SD.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"5.5","spread":"4.19"},{"groupId":"BG001","value":"5.5","spread":"3.88"},{"groupId":"BG002","value":"5.5","spread":"4.04"}]}]}]},{"title":"Sheehan Disability Scale (SDS)","description":"The SDS is completed by the participants and is used to assess the effect of their symptoms on work (Item 1), social (Item 2) and family life (Item 3). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Total scores is the sum of the 3 items and range from 0-30 with higher values indicating greater disruption in the participant's work/social/family life. There were 118 participants in Duloxetine group and 128 participants in Pregabalin group who had missing data and were not included in the calculation of mean and SD.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"13.3","spread":"7.47"},{"groupId":"BG001","value":"13.3","spread":"7.59"},{"groupId":"BG002","value":"13.3","spread":"7.52"}]}]}]},{"title":"Average number of hours worked for pay per week","description":"Data presented are average number of hours worked for pay per week during last 8 weeks prior to entering Study Period II. There were 275 participants in Duloxetine group and 281 participants in Pregabalin group who had missing data and were not included in the calculation of mean and SD.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"hours","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"39.5","spread":"20.33"},{"groupId":"BG001","value":"41.4","spread":"16.36"},{"groupId":"BG002","value":"40.4","spread":"18.47"}]}]}]},{"title":"Number of days of work/school missed","description":"Data presented are the number of days of work/school missed due to diabetic peripheral neuropathic pain (DPNP) during the last 8 weeks prior to entering Study Period II. There were 278 participants in Duloxetine group and 281 participants in Pregabalin group who had missing data and were not included in the calculation of mean and SD.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"days","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"2.3","spread":"7.98"},{"groupId":"BG001","value":"1.3","spread":"4.69"},{"groupId":"BG002","value":"1.8","spread":"6.56"}]}]}]},{"title":"Number of days hospitalized","description":"Data presented are the number of days hospitalized due to DPNP during the last 8 weeks prior to entering Study Period II. There were 21 participants in Duloxetine group and 23 participants in Pregabalin group who had missing data and were not included in the calculation of mean and SD.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"days","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0.0","spread":"0.45"},{"groupId":"BG001","value":"0.1","spread":"0.67"},{"groupId":"BG002","value":"0.1","spread":"0.57"}]}]}]},{"title":"Blood pressure (BP)","description":"One participant in both Duloxetine group and Pregabalin group had missing data and were not included in the calculation of mean and SD.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"millimeter of mercury (mm Hg)","classes":[{"title":"Systolic BP","categories":[{"measurements":[{"groupId":"BG000","value":"135.0","spread":"16.27"},{"groupId":"BG001","value":"134.3","spread":"15.62"},{"groupId":"BG002","value":"134.7","spread":"15.94"}]}]},{"title":"Diastolic BP","categories":[{"measurements":[{"groupId":"BG000","value":"77.6","spread":"10.04"},{"groupId":"BG001","value":"76.7","spread":"9.43"},{"groupId":"BG002","value":"77.1","spread":"9.74"}]}]}]},{"title":"Pulse rate","description":"Three participants in Duloxetine group and 1 participant in Pregabalin group had missing data and were not included in the calculation of mean and SD.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"beats per minute (bpm)","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"76.0","spread":"10.81"},{"groupId":"BG001","value":"75.6","spread":"11.05"},{"groupId":"BG002","value":"75.8","spread":"10.92"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change From Week 8 to Week 16 Endpoint in 24 Hour Average Pain Item Score on the Brief Pain Inventory (BPI) Modified Short Form","description":"BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment\\*visit, baseline\\*visit and treatment in Study Period II.","populationDescription":"All randomized participants who received at least one dose of study drug, and had Week 8 and at least one BPI measurements during Weeks 9-16 (Study Period III).","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"units on a scale","timeFrame":"Week 8, Week 16","groups":[{"id":"OG000","title":"Combination","description":"All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram \\[mg\\] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together."},{"id":"OG001","title":"Monotherapy","description":"All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"169"},{"groupId":"OG001","value":"170"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.353","lowerLimit":"-2.688","upperLimit":"-2.017"},{"groupId":"OG001","value":"-2.161","lowerLimit":"-2.509","upperLimit":"-1.812"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.370","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Differences (Final Values)","paramValue":"-0.192","ciPctValue":"95"}]},{"type":"OTHER_PRE_SPECIFIED","title":"Mean Change From Baseline to Week 8 Endpoint in 24 Hour Average Pain Item Score on the Brief Pain Inventory (BPI) Modified Short Form","description":"BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment\\*visit and baseline\\*visit.","populationDescription":"All randomized participants who received at least one dose of study drug, and had baseline and at least one post-baseline BPI measurements during Weeks 1-8 (Study Period II).","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"90% Confidence Interval","unitOfMeasure":"units on a scale","timeFrame":"Baseline, Week 8","groups":[{"id":"OG000","title":"Duloxetine","description":"Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II."},{"id":"OG001","title":"Pregabalin","description":"Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"401"},{"groupId":"OG001","value":"401"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.295","lowerLimit":"-2.508","upperLimit":"-2.083"},{"groupId":"OG001","value":"-1.682","lowerLimit":"-1.893","upperLimit":"-1.471"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Differences (Final Values)","paramValue":"-0.614","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Mean Change From Week 8 to Week 16 Endpoint in Items of the Brief Pain Inventory (BPI) Modified Short Form Worst Pain Score","description":"BPI Modified Short Form worst pain score is a self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment\\*visit, baseline\\*visit and treatment in Study Period II.","populationDescription":"All randomized participants who received at least one dose of study drug, and had Week 8 and at least one BPI measurements during Weeks 9-16 (Study Period III).","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"units on a scale","timeFrame":"Week 8, Week 16","groups":[{"id":"OG000","title":"Combination","description":"All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram \\[mg\\] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together."},{"id":"OG001","title":"Monotherapy","description":"All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"169"},{"groupId":"OG001","value":"170"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.374","lowerLimit":"-2.757","upperLimit":"-1.990"},{"groupId":"OG001","value":"-2.371","lowerLimit":"-2.771","upperLimit":"-1.971"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.991","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Differences (Final Values)","paramValue":"-0.003","ciPctValue":"95"}]},{"type":"OTHER_PRE_SPECIFIED","title":"Percentage of Participants With a Reduction of Greater Than or Equal to 30% on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 8 Endpoint","description":"BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).","populationDescription":"All randomized participants who received at least one dose of study drug, and had baseline and at least one post-baseline BPI measurements during Weeks 1-8 (Study Period II). Last observation carried forward (LOCF) principle was used.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Baseline through Week 8","groups":[{"id":"OG000","title":"Duloxetine","description":"Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II."},{"id":"OG001","title":"Pregabalin","description":"Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"375"},{"groupId":"OG001","value":"374"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"52.0"},{"groupId":"OG001","value":"36.9"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Cochran-Mantel-Haenszel","paramType":"Risk Ratio (RR)","paramValue":"1.431","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.233","ciUpperLimit":"1.662"}]},{"type":"SECONDARY","title":"Percentage of Participants With a Reduction of Greater Than or Equal to 30% on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 16 Endpoint","description":"BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).","populationDescription":"All randomized participants who received at least one dose of study drug, and had Week 8 and at least one BPI measurements during Weeks 9-16 (Study Period III). Last observation carried forward (LOCF) principle was used.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Week 8 through Week 16","groups":[{"id":"OG000","title":"Combination","description":"All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram \\[mg\\] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together."},{"id":"OG001","title":"Monotherapy","description":"All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"165"},{"groupId":"OG001","value":"163"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"61.8"},{"groupId":"OG001","value":"55.8"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.565","statisticalMethod":"Cochran-Mantel-Haenszel","paramType":"Risk Ratio (RR)","paramValue":"1.052","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.884","ciUpperLimit":"1.253"}]},{"type":"OTHER_PRE_SPECIFIED","title":"Percentage of Participants With a Reduction of Greater Than or Equal to 50% on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 8 Endpoint","description":"BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).","populationDescription":"All randomized participants who received at least one dose of study drug, and had baseline and at least one post-baseline BPI measurements during Weeks 1-8 (Study Period II). Last observation carried forward (LOCF) principle was used.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Baseline through Week 8","groups":[{"id":"OG000","title":"Duloxetine","description":"Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II."},{"id":"OG001","title":"Pregabalin","description":"Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"375"},{"groupId":"OG001","value":"374"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"40.3"},{"groupId":"OG001","value":"27.8"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Cochran-Mantel-Haenszel","paramType":"Risk Ratio (RR)","paramValue":"1.467","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.214","ciUpperLimit":"1.771"}]},{"type":"SECONDARY","title":"Percentage of Participants With a Reduction of Greater Than or Equal to 50% on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 16 Endpoint","description":"BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).","populationDescription":"All randomized participants who received at least one dose of study drug, and had Week 8 and at least one BPI measurements during Weeks 9-16 (Study Period III). Last observation carried forward (LOCF) principle was used.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Week 8 through Week 16","groups":[{"id":"OG000","title":"Combination","description":"All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram \\[mg\\] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together."},{"id":"OG001","title":"Monotherapy","description":"All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"165"},{"groupId":"OG001","value":"163"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"52.1"},{"groupId":"OG001","value":"39.3"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.068","statisticalMethod":"Cochran-Mantel-Haenszel","paramType":"Risk Ratio (RR)","paramValue":"1.233","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.980","ciUpperLimit":"1.550"}]},{"type":"OTHER_PRE_SPECIFIED","title":"Percentage of Participants With a Decrease of Greater Than or Equal to 2 Points on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 8 Endpoint","description":"BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).","populationDescription":"All randomized participants who received at least one dose of study drug, and had baseline and at least one post-baseline BPI measurements during Weeks 1-8 (Study Period II). Last observation carried forward (LOCF) principle was used.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Baseline through Week 8","groups":[{"id":"OG000","title":"Duloxetine","description":"Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II."},{"id":"OG001","title":"Pregabalin","description":"Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"375"},{"groupId":"OG001","value":"374"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"57.1"},{"groupId":"OG001","value":"45.7"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Cochran-Mantel-Haenszel","paramType":"Risk Ratio (RR)","paramValue":"1.279","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.125","ciUpperLimit":"1.456"}]},{"type":"SECONDARY","title":"Percentage of Participants With a Decrease of Greater Than or Equal to 2 Points on Brief Pain Inventory (BPI) Modified Short Form 24-Hour Average Pain Item Score at Week 16 Endpoint","description":"BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).","populationDescription":"All randomized participants who received at least one dose of study drug, and had Week 8 and at least one BPI measurements during Weeks 9-16 (Study Period III). Last observation carried forward (LOCF) principle was used.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Week 8 through Week 16","groups":[{"id":"OG000","title":"Combination","description":"All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram \\[mg\\] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together."},{"id":"OG001","title":"Monotherapy","description":"All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"165"},{"groupId":"OG001","value":"163"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"66.7"},{"groupId":"OG001","value":"64.4"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.843","statisticalMethod":"Cochran-Mantel-Haenszel","paramType":"Risk Ratio (RR)","paramValue":"0.985","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.842","ciUpperLimit":"1.151"}]},{"type":"OTHER_PRE_SPECIFIED","title":"Clinical Global Impression of Improvement (CGI-I) at Week 8 Endpoint","description":"Measures clinician's perception of participant improvement at the time of assessment compared with the start of treatment. Scores range from 1 (very much better) to 7 (very much worse). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, visit, and treatment\\*visit.","populationDescription":"All randomized participants who received at least one dose of study drug, and had at least one post-baseline CGI-I measurement during Weeks 1-8 (Study Period II).","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"units on a scale","timeFrame":"Week 8","groups":[{"id":"OG000","title":"Duloxetine","description":"Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II."},{"id":"OG001","title":"Pregabalin","description":"Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"400"},{"groupId":"OG001","value":"401"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.508","lowerLimit":"2.396","upperLimit":"2.619"},{"groupId":"OG001","value":"2.848","lowerLimit":"2.737","upperLimit":"2.959"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Final Values)","paramValue":"-0.341","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Clinical Global Impression of Improvement (CGI-I) at Week 16 Endpoint","description":"Measures clinician's perception of participant improvement at the time of assessment compared with the start of treatment for Study Period III. Scores range from 1 (very much better) to 7 (very much worse). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment\\*visit, baseline\\*visit and treatment in Study Period II.","populationDescription":"All randomized participants who received at least one dose of study drug, and had at least one CGI-I measurement during Weeks 9-16 (Study Period III).","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"units on a scale","timeFrame":"Week 16","groups":[{"id":"OG000","title":"Combination","description":"All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram \\[mg\\] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together."},{"id":"OG001","title":"Monotherapy","description":"All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"169"},{"groupId":"OG001","value":"170"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.286","lowerLimit":"2.127","upperLimit":"2.444"},{"groupId":"OG001","value":"2.359","lowerLimit":"2.193","upperLimit":"2.524"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.475","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Final Values)","paramValue":"-0.073","ciPctValue":"95"}]},{"type":"OTHER_PRE_SPECIFIED","title":"Mean Change From Baseline to Week 8 Endpoint on the Neuropathic Pain Symptom Inventory (NPSI) Questionnaire","description":"The NPSI is a 12-item self-administered questionnaire to assess 5 different dimensions of neuropathic pain: superficial spontaneous burning pain, deep spontaneous pressing pain, paroxysmal pain, evoked pains, and paresthesias/dysesthesias. A total score ranges from 0 to 100. Higher score indicates a greater intensity of pain. Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment\\*visit and baseline\\*visit.","populationDescription":"All randomized participants who received at least one dose of study drug, and had baseline and at least one post-baseline NPSI measurements during Weeks 1-8 (Study Period II).","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"units on a scale","timeFrame":"Baseline, Week 8","groups":[{"id":"OG000","title":"Duloxetine","description":"Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II."},{"id":"OG001","title":"Pregabalin","description":"Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"399"},{"groupId":"OG001","value":"397"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-19.442","lowerLimit":"-21.366","upperLimit":"-17.518"},{"groupId":"OG001","value":"-14.684","lowerLimit":"-16.606","upperLimit":"-12.762"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Final Values)","paramValue":"-4.758","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Mean Change From Week 8 to Week 16 Endpoint on the Neuropathic Pain Symptom Inventory (NPSI) Questionnaire","description":"The NPSI is a 12-item self-administered questionnaire to assess 5 different dimensions of neuropathic pain: superficial spontaneous burning pain, deep spontaneous pressing pain, paroxysmal pain, evoked pains, and paresthesias/dysesthesias. A total score ranges from 0 to 100. Higher score indicates a greater intensity of pain. Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment\\*visit, baseline\\*visit and treatment in Study Period II.","populationDescription":"All randomized participants who received at least one dose of study drug, and had Week 8 and at least one NPSI measurements during Weeks 9-16 (Study Period III).","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"units on a scale","timeFrame":"Week 8, Week 16","groups":[{"id":"OG000","title":"Combination","description":"All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram \\[mg\\] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together."},{"id":"OG001","title":"Monotherapy","description":"All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"169"},{"groupId":"OG001","value":"170"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-13.734","lowerLimit":"-16.588","upperLimit":"-10.880"},{"groupId":"OG001","value":"-11.801","lowerLimit":"-14.774","upperLimit":"-8.828"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.289","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Final Values)","paramValue":"-1.933","ciPctValue":"95"}]},{"type":"OTHER_PRE_SPECIFIED","title":"Mean Change From Baseline to Week 8 Endpoint in Sheehan Disability Scale (SDS)","description":"The SDS is completed by the participant and is used to assess the effect of the participant's symptoms on their work (Item 1), social (Item 2), and family life (Item 3). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Total scores is the sum of the 3 items and range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. Least Squares (LS) mean values are controlled for treatment, site, baseline value and treatment\\*site.","populationDescription":"All randomized participants who received at least one dose of study drug, and had baseline and at least one post-baseline SDS measurement during Weeks 1-8 (Study Period II). Last observation carried forward (LOCF) principle was used.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"units on a scale","timeFrame":"Baseline, Week 8","groups":[{"id":"OG000","title":"Duloxetine","description":"Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II."},{"id":"OG001","title":"Pregabalin","description":"Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"235"},{"groupId":"OG001","value":"234"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-4.387","lowerLimit":"-5.185","upperLimit":"-3.590"},{"groupId":"OG001","value":"-3.367","lowerLimit":"-4.133","upperLimit":"-2.601"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.071","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference (Final Values)","paramValue":"-1.020","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Mean Change From Week 8 to Week 16 Endpoint in Sheehan Disability Scale (SDS)","description":"The SDS is completed by the participant and is used to assess the effect of the participant's symptoms on their work (Item 1), social (Item 2), and family life (Item 3). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Total scores is the sum of the 3 items and range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. Least Squares (LS) Mean values are controlled for treatment, site, baseline value, treatment\\*site and treatment in Study Period II.","populationDescription":"All randomized participants who received at least one dose of study drug, and had Week 8 and at least one SDS measurement during Weeks 9-16 (Study Period III). Last observation carried forward (LOCF) principle was used.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"units on a scale","timeFrame":"Week 8, Week 16","groups":[{"id":"OG000","title":"Combination","description":"All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram \\[mg\\] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together."},{"id":"OG001","title":"Monotherapy","description":"All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"108"},{"groupId":"OG001","value":"106"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.625","lowerLimit":"-3.589","upperLimit":"-1.661"},{"groupId":"OG001","value":"-2.431","lowerLimit":"-3.410","upperLimit":"-1.453"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.780","statisticalMethod":"ANCOVA","paramType":"LS Mean Difference (Final Values)","paramValue":"-0.193","ciPctValue":"95"}]},{"type":"OTHER_PRE_SPECIFIED","title":"Mean Change From Baseline to Week 8 Endpoint in Hospital Anxiety and Depression Scale (HADS)","description":"A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale (0-3), giving maximum scores of 21 for anxiety and for depression. Scores of 11 or more on either subscale are considered to be a significant case of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7 represent 'normal.' Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment\\*visit and baseline\\*visit.","populationDescription":"All randomized participants who received at least one dose of study drug, and had baseline and at least one post-baseline HADS measurements during Weeks 1-8 (Study Period II).","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"units on a scale","timeFrame":"Baseline, Week 8","groups":[{"id":"OG000","title":"Duloxetine","description":"Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II."},{"id":"OG001","title":"Pregabalin","description":"Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"399"},{"groupId":"OG001","value":"402"}]}],"classes":[{"title":"Anxiety Subscale Score (n= 398, 400)","categories":[{"measurements":[{"groupId":"OG000","value":"-1.991","lowerLimit":"-2.301","upperLimit":"-1.681"},{"groupId":"OG001","value":"-1.433","lowerLimit":"-1.739","upperLimit":"-1.127"}]}]},{"title":"Depression Subscale Score","categories":[{"measurements":[{"groupId":"OG000","value":"-1.064","lowerLimit":"-1.351","upperLimit":"-0.778"},{"groupId":"OG001","value":"-0.642","lowerLimit":"-0.925","upperLimit":"-0.359"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.008","pValueComment":"P-value is for anxiety subscale score.","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Final Values)","paramValue":"-0.558","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.031","pValueComment":"p-value is for depression subscale score.","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Final Values)","paramValue":"-0.423","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Mean Change From Week 8 to Week 16 Endpoint in Hospital Anxiety and Depression Scale (HADS)","description":"A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale (0-3), giving maximum scores of 21 for anxiety and for depression. Scores of 11 or more on either subscale are considered to be a significant case of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7 represent 'normal.' Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment\\*visit, baseline\\*visit and treatment in Study Period II.","populationDescription":"All randomized participants who received at least one dose of study drug, and had Week 8 and at least one HADS measurements during Weeks 9-16 (Study Period III).","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"units on a scale","timeFrame":"Week 8, Week 16","groups":[{"id":"OG000","title":"Combination","description":"All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram \\[mg\\] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together."},{"id":"OG001","title":"Monotherapy","description":"All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"169"},{"groupId":"OG001","value":"170"}]}],"classes":[{"title":"Anxiety Subscale Score (n=169, 169)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.860","lowerLimit":"-1.342","upperLimit":"-0.377"},{"groupId":"OG001","value":"-0.245","lowerLimit":"-0.742","upperLimit":"0.253"}]}]},{"title":"Depression Subscale Score (n=168, 170)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.461","lowerLimit":"-0.916","upperLimit":"-0.007"},{"groupId":"OG001","value":"-0.083","lowerLimit":"-0.550","upperLimit":"0.384"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.049","pValueComment":"P-value is for anxiety subscale score.","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Final Values)","paramValue":"-0.615","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.198","pValueComment":"P-value is for depression subscale score.","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference (Final Values)","paramValue":"-0.378","ciPctValue":"95"}]},{"type":"OTHER_PRE_SPECIFIED","title":"Resource Utilization (Number of Days Hospitalized, Number of Days of Sick Leave) Baseline Through Week 8","description":"Data presented are the number of days hospitalized and work/school missed (sick leave) due to diabetic peripheral neuropathic pain (DPNP) during the last 8 weeks.","populationDescription":"All randomized participants who received at least one dose of study drug and provided information of hospitalization and sick leave during Weeks 1-8 (Study Period II).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"days","timeFrame":"Baseline through Week 8","groups":[{"id":"OG000","title":"Duloxetine","description":"Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II."},{"id":"OG001","title":"Pregabalin","description":"Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"314"},{"groupId":"OG001","value":"319"}]}],"classes":[{"title":"Days hospitalized","categories":[{"measurements":[{"groupId":"OG000","value":"0","spread":"0.00"},{"groupId":"OG001","value":"0","spread":"0.00"}]}]},{"title":"Days of sick leave (n=108, 101)","categories":[{"measurements":[{"groupId":"OG000","value":"1.9","spread":"8.34"},{"groupId":"OG001","value":"0.3","spread":"2.04"}]}]}]},{"type":"SECONDARY","title":"Resource Utilization (Number of Days Hospitalized, Number of Days of Sick Leave) Week 8 Through Week 16","description":"Data presented are the number of days hospitalized and work/school missed (sick leave) due to diabetic peripheral neuropathic pain (DPNP) during the last 8 weeks.","populationDescription":"All randomized participants who received at least one dose of study drug and provided information of hospitalization and sick leave during Weeks 9-16 (Study Period III).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"days","timeFrame":"Week 8 through Week 16","groups":[{"id":"OG000","title":"Combination","description":"All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram \\[mg\\] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together."},{"id":"OG001","title":"Monotherapy","description":"All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"140"},{"groupId":"OG001","value":"146"}]}],"classes":[{"title":"Days hospitalized (n=140, 146)","categories":[{"measurements":[{"groupId":"OG000","value":"0","spread":"0.00"},{"groupId":"OG001","value":"0","spread":"0.00"}]}]},{"title":"Days of sick leave (n=41, 36)","categories":[{"measurements":[{"groupId":"OG000","value":"0.1","spread":"0.65"},{"groupId":"OG001","value":"0.4","spread":"2.67"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Average Number of Hours Worked for Pay Per Week Baseline Through Week 8","description":"Data presented are the average number of hours worked for pay per week during the last 8 weeks.","populationDescription":"All randomized participants who received at least one dose of study drug and had worked for pay during Weeks 1-8 (Study Period II).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"hours","timeFrame":"Baseline through Week 8","groups":[{"id":"OG000","title":"Duloxetine","description":"Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II."},{"id":"OG001","title":"Pregabalin","description":"Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"102"},{"groupId":"OG001","value":"100"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"37.6","spread":"18.72"},{"groupId":"OG001","value":"42.4","spread":"15.52"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Average Number of Hours Worked for Pay Per Week Week 8 Through Week 16","description":"Data presented are the average number of hours worked for pay per week during the last 8 weeks.","populationDescription":"All randomized participants who received at least one dose of study drug and had worked for pay during Weeks 9-16 (Study Period III).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"hours","timeFrame":"Week 8 through Week 16","groups":[{"id":"OG000","title":"Combination","description":"All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram \\[mg\\] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together."},{"id":"OG001","title":"Monotherapy","description":"All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"36"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"39.8","spread":"15.98"},{"groupId":"OG001","value":"34.7","spread":"21.46"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Patient Global Impression of Improvement (PGI-I) Score at Week 8 Endpoint","description":"Measures 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). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). 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