{"protocolSection":{"identificationModule":{"nctId":"NCT00314249","orgStudyIdInfo":{"id":"MLN-MD-03"},"organization":{"fullName":"Forest Laboratories","class":"INDUSTRY"},"briefTitle":"Study of Milnacipran for the Treatment of Fibromyalgia","officialTitle":"A Phase III Pivotal, Multicenter, Double-blind, Randomized, Placebo-Controlled Monotherapy Study of Milnacipran for the Treatment of Fibromyalgia."},"statusModule":{"statusVerifiedDate":"2010-01","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2006-04"},"primaryCompletionDateStruct":{"date":"2008-06","type":"ACTUAL"},"studyFirstSubmitDate":"2006-04-11","studyFirstSubmitQcDate":"2006-04-11","studyFirstPostDateStruct":{"date":"2006-04-13","type":"ESTIMATED"},"resultsFirstSubmitDate":"2009-06-30","resultsFirstSubmitQcDate":"2009-09-25","resultsFirstPostDateStruct":{"date":"2009-11-02","type":"ESTIMATED"},"lastUpdateSubmitDate":"2010-01-14","lastUpdatePostDateStruct":{"date":"2010-01-20","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"oldNameTitle":"Robert Palmer, MD","oldOrganization":"Forest Research Institute, a subsidiary of Forest Laboratories, Inc."},"leadSponsor":{"name":"Forest Laboratories","class":"INDUSTRY"},"collaborators":[{"name":"Cypress Bioscience, Inc.","class":"INDUSTRY"}]},"descriptionModule":{"briefSummary":"The purpose of this study was to demonstrate the efficacy and safety of milnacipran at a dosage of 100 mg/day in the treatment of the fibromyalgia syndrome or the pain associate with fibromyalgia."},"conditionsModule":{"conditions":["Fibromyalgia"],"keywords":["Fibromyalgia"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":1025,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Placebo, oral administration, twice daily for 12 weeks","interventionNames":["Drug: Placebo"]},{"label":"Milnacipran","type":"EXPERIMENTAL","description":"Milnacipran 100mg/day (50mg BID \\[twice a day\\])","interventionNames":["Drug: Milnacipran 100mg"]}],"interventions":[{"type":"DRUG","name":"Placebo","description":"Placebo, oral administration, twice daily for 12 weeks","armGroupLabels":["Placebo"]},{"type":"DRUG","name":"Milnacipran 100mg","description":"Milnacipran 100mg per day (50mg BID \\[twice a day\\])","armGroupLabels":["Milnacipran"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Composite Syndrome Responder Status","description":"Composite Syndrome Responder Status is the number of responders based on 3 domains: (1) 30% reduction in pain (as recorded in the Patient Experience Diary \\[PED\\], electronic diary, during the morning report; 24 hour recall); (2) patient global impression of change (PGIC) score of \"very much improved\" and \"much improved;\" and (3) physical function improvement of 6 or more points on Short Form-36 Physical Component Summary (SF-36 PCS)","timeFrame":"At the end of the three-month stable dose treatment phase"},{"measure":"Composite Pain Responder Status","description":"Composite Pain Responder Status is the number of responders based on two domains: (1) 30% reduction in pain (as recorded in the Patient Experience Diary \\[PED\\], electronic diary, during the morning report; 24 hour recall); and (2) Patient Global Impression of Change (PGIC) score of \"very much improved\" or \"much improved.\"","timeFrame":"At the end of three-month stable dose treatment phase"}],"secondaryOutcomes":[{"measure":"Time-Weighted Average of Patient Experience Diary (PED) Reported Morning 24-Hour Recall Pain Scores for Weeks 1-12 of the Stable Dose Phase","description":"Time-weighted average (area under the curve \\[AUC\\]) of the weekly average Patient Experience Diary (PED)-reported morning recall pain scores for weeks 1 through 12 of the stable dose treatment phase is the area under the Patient Experience Diary (PED)-time curve estimated using the trapezoidal method and normalized by time.\n\nPED is the Patient Experience Diary, an electronic diary system used for collection of patient self-reported pain data. Outcome measure is assessed using the VAS Pain Intensity Scale from 0-100 millimeters anchored at 0 mm (no pain) to 100 mm (worst possible pain).","timeFrame":"Weeks 1 through 12 of the stable dose treatment phase (Visit TX0-TX12)"},{"measure":"Time-Weighted Average of Patient Global Impression of Change (PGIC) From Visit TX0-TX12.","description":"Time-weighted average (area under the curve \\[AUC\\]) for Patient Global Impression of Change (PGIC) from Visit TX0-TX12 is the area under the PGIC-time curve estimated using the trapezoidal method and normalized by time.\n\nPGIC is an efficacy assessment on a scale of 1-7 taken at visits TX0-TX12. The wording of the assessment is as follows: \"Since the start of the study, overall my fibromyalgia is:\" 1=Very Much Improved, 2=Much Improved, 3=Minimally Improved, 4=No Change, 5=Minimally Worse, 6=Much Worse, and 7-Very Much Worse.","timeFrame":"Weeks 1-12 (Visit TX0-TX12) of the stable dose treatment phase"},{"measure":"Change From Baseline in the Multi-Dimensional Fatigue Inventory (MFI) Total Score at Visit TX12.","description":"Change from Baseline in the Multi-Dimensional Fatigue Inventory (MFI) total score at TX12. Negative differences indicate decrease of fatigue.\n\nMFI is a subjective report of fatigue symptoms consisting of 20 items that can be scored to produce 5 dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. The MFI is a 1-5 scale with 1=\"yes, that is true\" and 5=\"no, that is not true.\"","timeFrame":"Baseline through end of week 12 (Visit TX12)"},{"measure":"Time-Weighted Average of the Short Form-36 Physical Component Summary (SF-36 PCS) Score From Visit TX0-TX12","description":"Short Form-36 (SF-36): pt. questionnaire (36 questions) which give rise to 8 domains \\& 2 component summaries (mental and physical); assessing quality of life, health \\& functional status.\n\nSF-36 PCS: weighted summary of physical function using all 8 domains.\n\nScores are standardized so that the range for all domains and component summaries is 0 (worst possible score) to 100 (best possible score). Higher scores indicate better health or functional status.\n\nSF-36 PCS AUC (Area under the Curve): estimated using trapezoidal method, normalized by time.","timeFrame":"Weeks 1-12 (Visit TX0-TX12) of the stable dose treatment phase"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) Criteria\n\nExclusion Criteria:\n\n* psychiatric illness,\n* depression,\n* suicidal risk,\n* substance abuse,\n* pulmonary dysfunction,\n* renal impairment,\n* active cardiac disease,\n* liver disease,\n* autoimmune disease,\n* cancer,\n* inflammatory bowel disease","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"70 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"locations":[{"facility":"Forest Investigative Site","city":"Tuscaloosa","state":"Alabama","zip":"35406","country":"United States","geoPoint":{"lat":33.20984,"lon":-87.56917}},{"facility":"Forest Investigative Site","city":"Fresno","state":"California","zip":"93710","country":"United States","geoPoint":{"lat":36.74773,"lon":-119.77237}},{"facility":"Forest Investigative Site","city":"Pismo Beach","state":"California","zip":"93449","country":"United States","geoPoint":{"lat":35.14275,"lon":-120.64128}},{"facility":"Forest Investigative Site","city":"Vista","state":"California","zip":"92083","country":"United States","geoPoint":{"lat":33.20004,"lon":-117.24254}},{"facility":"Forest Investigative Site","city":"St. Petersburg","state":"Florida","zip":"33702","country":"United States","geoPoint":{"lat":27.77086,"lon":-82.67927}},{"facility":"Forest Investigative Site","city":"St. Petersburg","state":"Florida","zip":"33709","country":"United States","geoPoint":{"lat":27.77086,"lon":-82.67927}},{"facility":"Forest Investigative Site","city":"Stuart","state":"Florida","zip":"34996","country":"United States","geoPoint":{"lat":27.19755,"lon":-80.25283}},{"facility":"Forest Investigative Site","city":"Atlanta","state":"Georgia","zip":"30328","country":"United States","geoPoint":{"lat":33.749,"lon":-84.38798}},{"facility":"Forest Investigative Site","city":"Springfield","state":"Massachusetts","zip":"01107","country":"United States","geoPoint":{"lat":42.10148,"lon":-72.58981}},{"facility":"Forest Investigative Site","city":"Worcester","state":"Massachusetts","zip":"01610","country":"United States","geoPoint":{"lat":42.26259,"lon":-71.80229}},{"facility":"Forest Investigative Site","city":"Omaha","state":"Nebraska","zip":"68134","country":"United States","geoPoint":{"lat":41.25626,"lon":-95.94043}},{"facility":"Forest Investigative Site","city":"Haddon Heights","state":"New Jersey","zip":"08035","country":"United States","geoPoint":{"lat":39.87734,"lon":-75.06462}},{"facility":"Forest Investigative Site","city":"Johnson City","state":"New York","zip":"13790","country":"United States","geoPoint":{"lat":42.11563,"lon":-75.95881}},{"facility":"Forest Investigative Site","city":"Syracuse","state":"New York","zip":"13210","country":"United States","geoPoint":{"lat":43.04812,"lon":-76.14742}},{"facility":"Forest Investigative Site","city":"Greensboro","state":"North Carolina","zip":"27408","country":"United States","geoPoint":{"lat":36.07264,"lon":-79.79198}},{"facility":"Forest Investigative Site","city":"Cleveland","state":"Ohio","zip":"44122","country":"United States","geoPoint":{"lat":41.4995,"lon":-81.69541}},{"facility":"Forest Investigative Site","city":"Columbus","state":"Ohio","zip":"43212","country":"United States","geoPoint":{"lat":39.96118,"lon":-82.99879}},{"facility":"Forest Investigative Site","city":"Toledo","state":"Ohio","zip":"43623","country":"United States","geoPoint":{"lat":41.66394,"lon":-83.55521}},{"facility":"Forest Investigative Site","city":"Eugene","state":"Oregon","zip":"97401","country":"United States","geoPoint":{"lat":44.05207,"lon":-123.08675}},{"facility":"Forest Investigative Site","city":"Mechanicsburg","state":"Pennsylvania","zip":"17055","country":"United States","geoPoint":{"lat":40.21426,"lon":-77.00859}},{"facility":"Forest Investigative Site","city":"Anderson","state":"South Carolina","zip":"29621","country":"United States","geoPoint":{"lat":34.50344,"lon":-82.65013}},{"facility":"Forest Investigative Site","city":"Greer","state":"South Carolina","zip":"29651","country":"United States","geoPoint":{"lat":34.93873,"lon":-82.22706}},{"facility":"Forest Investigative Site","city":"Richardson","state":"Texas","zip":"75080","country":"United States","geoPoint":{"lat":32.94818,"lon":-96.72972}},{"facility":"Forest Investigative Site","city":"Virginia Beach","state":"Virginia","zip":"23454","country":"United States","geoPoint":{"lat":36.85293,"lon":-75.97799}}]},"referencesModule":{"references":[{"pmid":"22429066","type":"DERIVED","citation":"Saxe PA, Arnold LM, Palmer RH, Gendreau RM, Chen W. Short-term (2-week) effects of discontinuing milnacipran in patients with fibromyalgia. Curr Med Res Opin. 2012 May;28(5):815-21. doi: 10.1185/03007995.2012.677418. Epub 2012 Apr 10."},{"pmid":"20496365","type":"DERIVED","citation":"Arnold LM, Gendreau RM, Palmer RH, Gendreau JF, Wang Y. Efficacy and safety of milnacipran 100 mg/day in patients with fibromyalgia: results of a randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2010 Sep;62(9):2745-56. doi: 10.1002/art.27559."}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Upon completion of the washout period, a two-week baseline period was completed prior to randomization. Patients were then randomized in a 1:1 ratio to either placebo or milnacipran 100 mg/day (50 mg BID \\[twice a day\\])","recruitmentDetails":"Recruitment period was from 4/28/06 through 12/27/07 with last patient last visit on 6/30/08 at 65 centers in the US and 3 centers in Canada","groups":[{"id":"FG000","title":"Placebo","description":"Placebo administered orally BID (twice a day) for 12 weeks of stable dose treatment phase"},{"id":"FG001","title":"Milnacipran","description":"Milnacipran 100 mg per day, administered orally (BID \\[twice a day\\]) for 12 weeks of stable dose treatment phase"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"509"},{"groupId":"FG001","numSubjects":"516"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"357"},{"groupId":"FG001","numSubjects":"353"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"152"},{"groupId":"FG001","numSubjects":"163"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"73"},{"groupId":"FG001","numSubjects":"94"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"33"},{"groupId":"FG001","numSubjects":"24"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"21"},{"groupId":"FG001","numSubjects":"28"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"15"},{"groupId":"FG001","numSubjects":"9"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Withdrawn for other reasons","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Non-Compliant","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"6"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Placebo","description":"Placebo administered orally BID (twice a day) for 12 weeks of stable dose treatment phase"},{"id":"BG001","title":"Milnacipran","description":"Milnacipran 100 mg per day, administered orally (BID \\[twice a day\\]) for 12 weeks of stable dose treatment phase"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"509"},{"groupId":"BG001","value":"516"},{"groupId":"BG002","value":"1025"}]}],"measures":[{"title":"Age Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"48.73","spread":"10.56"},{"groupId":"BG001","value":"49.07","spread":"10.79"},{"groupId":"BG002","value":"48.90","spread":"10.67"}]}]}]},{"title":"Age, Customized","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"<=20 years","categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"4"}]}]},{"title":"Between 20 and 60 years","categories":[{"measurements":[{"groupId":"BG000","value":"437"},{"groupId":"BG001","value":"429"},{"groupId":"BG002","value":"866"}]}]},{"title":">=60 years","categories":[{"measurements":[{"groupId":"BG000","value":"70"},{"groupId":"BG001","value":"85"},{"groupId":"BG002","value":"155"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"477"},{"groupId":"BG001","value":"500"},{"groupId":"BG002","value":"977"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"32"},{"groupId":"BG001","value":"16"},{"groupId":"BG002","value":"48"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"463"},{"groupId":"BG001","value":"469"},{"groupId":"BG002","value":"932"}]}]},{"title":"Canada","categories":[{"measurements":[{"groupId":"BG000","value":"46"},{"groupId":"BG001","value":"47"},{"groupId":"BG002","value":"93"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"SECONDARY","title":"Time-Weighted Average of Patient Experience Diary (PED) Reported Morning 24-Hour Recall Pain Scores for Weeks 1-12 of the Stable Dose Phase","description":"Time-weighted average (area under the curve \\[AUC\\]) of the weekly average Patient Experience Diary (PED)-reported morning recall pain scores for weeks 1 through 12 of the stable dose treatment phase is the area under the Patient Experience Diary (PED)-time curve estimated using the trapezoidal method and normalized by time.\n\nPED is the Patient Experience Diary, an electronic diary system used for collection of patient self-reported pain data. Outcome measure is assessed using the VAS Pain Intensity Scale from 0-100 millimeters anchored at 0 mm (no pain) to 100 mm (worst possible pain).","populationDescription":"The analysis was performed based on intent-to-treat population defined as all randomized patients who took at least one dose of double-blind study medication. For all subjects with missing assessments for weeks 1-12 of the stable dose treatment phase, values were imputed using last observation carried forward (LOCF).","reportingStatus":"POSTED","anticipatedPostingDate":"2009-06","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on scale","timeFrame":"Weeks 1 through 12 of the stable dose treatment phase (Visit TX0-TX12)","groups":[{"id":"OG000","title":"Placebo","description":"Placebo administered orally BID (twice a day) for 12 weeks of stable dose treatment phase"},{"id":"OG001","title":"Milnacipran","description":"Milnacipran 100 mg per day, administered orally (BID \\[twice a day\\]) for 12 weeks of stable dose treatment phase"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"509"},{"groupId":"OG001","value":"516"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"48.0","spread":"0.83"},{"groupId":"OG001","value":"41.2","spread":"0.87"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"This parameter was analyzed using an ANCOVA model with treatment group and study center as factors and baseline value as a covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"-6.38","ciPctValue":"95","ciLowerLimit":"-8.56","ciUpperLimit":"-4.19"}]},{"type":"SECONDARY","title":"Time-Weighted Average of Patient Global Impression of Change (PGIC) From Visit TX0-TX12.","description":"Time-weighted average (area under the curve \\[AUC\\]) for Patient Global Impression of Change (PGIC) from Visit TX0-TX12 is the area under the PGIC-time curve estimated using the trapezoidal method and normalized by time.\n\nPGIC is an efficacy assessment on a scale of 1-7 taken at visits TX0-TX12. The wording of the assessment is as follows: \"Since the start of the study, overall my fibromyalgia is:\" 1=Very Much Improved, 2=Much Improved, 3=Minimally Improved, 4=No Change, 5=Minimally Worse, 6=Much Worse, and 7-Very Much Worse.","populationDescription":"The analysis was performed based on intent-to-treat population defined as all randomized patients who took at least one dose of double-blind study medication. For all subjects with missing assessments from weeks 1-12 of the stable dose treatment phase, values were imputed using last observation carried forward (LOCF).","reportingStatus":"POSTED","anticipatedPostingDate":"2009-06","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on scale","timeFrame":"Weeks 1-12 (Visit TX0-TX12) of the stable dose treatment phase","groups":[{"id":"OG000","title":"Placebo","description":"Placebo administered orally BID (twice a day) for 12 weeks of stable dose treatment phase"},{"id":"OG001","title":"Milnacipran","description":"Milnacipran 100 mg per day, administered orally (BID \\[twice a day\\]) for 12 weeks of stable dose treatment phase"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"486"},{"groupId":"OG001","value":"495"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3.4","spread":"0.06"},{"groupId":"OG001","value":"2.9","spread":"0.06"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"This parameter was analyzed using an ANOVA model with treatment group and study center as factors.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","statisticalMethod":"ANOVA","paramType":"Mean Difference (Net)","paramValue":"-0.53","ciPctValue":"95","ciLowerLimit":"-0.69","ciUpperLimit":"-0.38"}]},{"type":"SECONDARY","title":"Change From Baseline in the Multi-Dimensional Fatigue Inventory (MFI) Total Score at Visit TX12.","description":"Change from Baseline in the Multi-Dimensional Fatigue Inventory (MFI) total score at TX12. Negative differences indicate decrease of fatigue.\n\nMFI is a subjective report of fatigue symptoms consisting of 20 items that can be scored to produce 5 dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. The MFI is a 1-5 scale with 1=\"yes, that is true\" and 5=\"no, that is not true.\"","populationDescription":"The analysis was performed based on intent-to-treat population defined as all randomized patients who took at least one dose of double-blind study medication. For all subjects with missing assessments at the end of week 12 (Visit TX12), values were imputed using Last Observation Carried Forward (LOCF).","reportingStatus":"POSTED","anticipatedPostingDate":"2009-06","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on scale","timeFrame":"Baseline through end of week 12 (Visit TX12)","groups":[{"id":"OG000","title":"Placebo","description":"Placebo administered orally BID (twice a day) for 12 weeks of stable dose treatment phase"},{"id":"OG001","title":"Milnacipran","description":"Milnacipran 100 mg per day, administered orally (BID \\[twice a day\\]) for 12 weeks of stable dose treatment phase"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"502"},{"groupId":"OG001","value":"508"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-3.96","spread":"0.549"},{"groupId":"OG001","value":"-5.50","spread":"0.599"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"This parameter was analyzed using an ANCOVA model with treatment group and study center as factors and baseline value as a covariate.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","statisticalMethod":"ANCOVA","paramType":"Mean Difference (Net)","paramValue":"-1.69","ciPctValue":"95","ciLowerLimit":"-3.27","ciUpperLimit":"-0.11"}]},{"type":"PRIMARY","title":"Composite Syndrome Responder Status","description":"Composite Syndrome Responder Status is the number of responders based on 3 domains: (1) 30% reduction in pain (as recorded in the Patient Experience Diary \\[PED\\], electronic diary, during the morning report; 24 hour recall); (2) patient global impression of change (PGIC) score of \"very much improved\" and \"much improved;\" and (3) physical function improvement of 6 or more points on Short Form-36 Physical Component Summary (SF-36 PCS)","populationDescription":"The primary efficacy analysis was performed based on intent-to-treat population defined as all randomized patients who took at least one dose of double-blind study medication. All subjects with missing assessments at the end of the three-month stable dose treatment phase were considered non-responders (baseline value carried forward (BOCF)).","reportingStatus":"POSTED","anticipatedPostingDate":"2009-06","paramType":"NUMBER","unitOfMeasure":"Syndrome Responder Participants","timeFrame":"At the end of the three-month stable dose treatment phase","groups":[{"id":"OG000","title":"Placebo","description":"Placebo administered orally BID (twice a day) for 12 weeks of stable dose treatment phase"},{"id":"OG001","title":"Milnacipran","description":"Milnacipran 100 mg per day, administered orally (BID \\[twice a day\\]) for 12 weeks of stable dose treatment phase"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"509"},{"groupId":"OG001","value":"516"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"56"},{"groupId":"OG001","value":"103"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"The test of no difference in the responder rate between milnacipran and placebo groups was performed using a logistic regression model with treatment group, baseline pain score, and baseline SF-36 PCS score as explanatory variables.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Closed testing procedure used to control overall type 1 error rate at 5%: fibromyalgia syndrome tested prior to fibromyalgia pain","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"2.06","ciPctValue":"95","ciLowerLimit":"1.45","ciUpperLimit":"2.94"}]},{"type":"PRIMARY","title":"Composite Pain Responder Status","description":"Composite Pain Responder Status is the number of responders based on two domains: (1) 30% reduction in pain (as recorded in the Patient Experience Diary \\[PED\\], electronic diary, during the morning report; 24 hour recall); and (2) Patient Global Impression of Change (PGIC) score of \"very much improved\" or \"much improved.\"","populationDescription":"The primary efficacy analysis was performed based on intent-to-treat population defined as all randomized patients who took at least one dose of double-blind study medication. All subjects with missing assessments at the end of three-month stable dose treatment phase were considered non-responders (baseline value carried forward (BOCF)).","reportingStatus":"POSTED","anticipatedPostingDate":"2009-06","paramType":"NUMBER","unitOfMeasure":"Pain Responder Participants","timeFrame":"At the end of three-month stable dose treatment phase","groups":[{"id":"OG000","title":"Placebo","description":"Placebo administered orally BID (twice a day) for 12 weeks of stable dose treatment phase"},{"id":"OG001","title":"Milnacipran","description":"Milnacipran 100 mg per day, administered orally (BID \\[twice a day\\]) for 12 weeks of stable dose treatment phase"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"509"},{"groupId":"OG001","value":"516"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"90"},{"groupId":"OG001","value":"147"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"The test of no difference in the responder rate between milnacipran and placebo groups was performed using a logistic regression model with the treatment group and baseline pain score as explanatory variables.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Closed testing procedure was used to control overall type 1 error rate at 5%: fibromyalgia pain tested after statistically significant fibromyalgia syndrome test","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"1.86","ciPctValue":"95","ciLowerLimit":"1.38","ciUpperLimit":"2.51"}]},{"type":"SECONDARY","title":"Time-Weighted Average of the Short Form-36 Physical Component Summary (SF-36 PCS) Score From Visit TX0-TX12","description":"Short Form-36 (SF-36): pt. questionnaire (36 questions) which give rise to 8 domains \\& 2 component summaries (mental and physical); assessing quality of life, health \\& functional status.\n\nSF-36 PCS: weighted summary of physical function using all 8 domains.\n\nScores are standardized so that the range for all domains and component summaries is 0 (worst possible score) to 100 (best possible score). Higher scores indicate better health or functional status.\n\nSF-36 PCS AUC (Area under the Curve): estimated using trapezoidal method, normalized by time.","populationDescription":"The analysis was performed based on intent-to-treat population defined as all randomized patients who took at least one dose of double-blind study medication. 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