Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-26 @ 1:24 AM
Study NCT ID:
NCT00436033
Status:
COMPLETED
Last Update Posted:
2013-07-11
First Post:
2007-02-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Multicentre Trial to Determine the Efficacy and Safety of Milnacipran in the Treatment of Fibromyalgia Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078764', 'term': 'Milnacipran'}], 'ancestors': [{'id': 'D003521', 'term': 'Cyclopropanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1429}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-10', 'studyFirstSubmitDate': '2007-02-15', 'studyFirstSubmitQcDate': '2007-02-15', 'lastUpdatePostDateStruct': {'date': '2013-07-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-02-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To demonstrate the efficacy of treatment with milnacipran as compared to placebo in the treatment of the fibromyalgia syndrome in outpatients after a 12-week period of fixed dose exposure through a primary composite criterion', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'comparison of efficacy of treatment with milnacipran to placebo on additional secondary criteria', 'timeFrame': '12 weeks'}, {'measure': 'establishment of safety profile of treatment of milnacipran in patients with fibromyalgia syndrome (FMS).', 'timeFrame': '19 weeks'}]}, 'conditionsModule': {'conditions': ['Fibromyalgia Syndrome']}, 'referencesModule': {'references': [{'pmid': '20156949', 'type': 'DERIVED', 'citation': 'Branco JC, Zachrisson O, Perrot S, Mainguy Y; Multinational Coordinator Study Group. A European multicenter randomized double-blind placebo-controlled monotherapy clinical trial of milnacipran in treatment of fibromyalgia. J Rheumatol. 2010 Apr;37(4):851-9. doi: 10.3899/jrheum.090884. Epub 2010 Feb 15.'}]}, 'descriptionModule': {'briefSummary': 'Investigation of efficacy and safety of treatment with milnacipran in the treatment of fibromyalgia syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient with a diagnosis of fibromyalgia according to the 1990 American College of Rheumatology (ACR) criteria\n\nExclusion Criteria:\n\n* psychiatric illness\n* depression of generalised anxiety disorder\n* suicidal risk\n* substance abuse\n* active cardiac disease\n* pulmonary dysfunction\n* liver disease\n* renal impairment\n* autoimmune disease\n* chronic inflammatory rheumatoid disease\n* current systemic infection\n* epileptic\n* active cancer\n* sleep apnea\n* active peptic ulcer\n* inflammatory bowel disease\n* unstable endocrine disease\n* for men : prostatic enlargement of genito-urinary disorders\n* for women : pregnancy or breast feeding'}, 'identificationModule': {'nctId': 'NCT00436033', 'briefTitle': 'A Multicentre Trial to Determine the Efficacy and Safety of Milnacipran in the Treatment of Fibromyalgia Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pierre Fabre Medicament'}, 'officialTitle': 'A European Phase III, Multicentre, Double-blind, Randomised, Placebo-controlled Monotherapy Study of Milnacipran for the Treatment of Fibromyalgia Syndrome', 'orgStudyIdInfo': {'id': 'F02207GE302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Minalcipran', 'interventionNames': ['Drug: milnacipran']}], 'interventions': [{'name': 'milnacipran', 'type': 'DRUG', 'armGroupLabels': ['Minalcipran']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '530 02', 'city': 'Pardubice', 'country': 'Czechia', 'facility': 'Rheumatology Ambulance', 'geoPoint': {'lat': 50.04075, 'lon': 15.77659}}, {'zip': 'F2000', 'city': 'Frederiksberg', 'country': 'Denmark', 'facility': 'FREDERIKSBERG HOSPITAL - Clinic of Rheumatology', 'geoPoint': {'lat': 55.67938, 'lon': 12.53463}}, {'zip': '70100', 'city': 'Kuopio', 'country': 'Finland', 'facility': 'Kuopion Oma Laakari Oy', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hopital Hotel Dieu', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': 'D50931', 'city': 'Cologne', 'country': 'Germany', 'facility': 'KKSK KLINIKUM DER UNIVERSITAET ZU KOELN - Anaesthesiology and Intensive Care', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '20157', 'city': 'Milan', 'country': 'Italy', 'facility': 'Ospedale Luigi Sacco', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '2609', 'city': 'Lillehamer', 'country': 'Norway', 'facility': 'Center For Clinical Studies'}, {'city': 'Torun', 'country': 'Poland', 'facility': '"Nasz Lekarz"', 'geoPoint': {'lat': 53.01375, 'lon': 18.59814}}, {'zip': '1349-019', 'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Hospital Egas Moniz', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '020475', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Dr I CANTACUZINO CLINICAL HOSPITAL', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '08024', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de La Esperanza', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '43137', 'city': 'Mölndal', 'country': 'Sweden', 'facility': 'Gottfriesclinic Ab', 'geoPoint': {'lat': 57.6554, 'lon': 12.01378}}, {'zip': 'SE59RJ', 'city': 'London', 'country': 'United Kingdom', 'facility': 'KINGS COLLEGE HOSPITAL - Clinic Trial Unit Academic Department of Rheumatology', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Dr Jaime C BRANCO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HOSPITAL EGAS MONIZ'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pierre Fabre Medicament', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}