Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2025-12-28 @ 9:54 AM
Study NCT ID:
NCT00424892
Status:
COMPLETED
Last Update Posted:
2007-12-06
First Post:
2007-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Evaluating DVS SR in Patients With 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-12-04', 'studyFirstSubmitDate': '2007-01-18', 'studyFirstSubmitQcDate': '2007-01-18', 'lastUpdatePostDateStruct': {'date': '2007-12-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-01-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The following assessments are made to assess safety: physical examination, vital signs, standard 12-lead ECG, laboratory determinations, adverse events and serious adverse events, BDI-II.'}], 'secondaryOutcomes': [{'measure': 'Pain score on the Numeric Rating Scale, FIQ score, PGIC, MAF, CGIC, Patient Global Symptom Rating and Physician Global Rating, MTPS, MOS-Sleep Measure.'}]}, 'conditionsModule': {'conditions': ['Fibromyalgia']}, 'descriptionModule': {'briefSummary': 'The primary objective is to evaluate the long-term safety of desvenlafaxine succinate sustained-release (DVS SR) during open-label treatment in adult outpatients with fibromyalgia syndrome.', 'detailedDescription': 'Patients completing study 3151A4-327 have the opportunity to be treated with DVS SR during the 6 month extension study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Outpatients who have completed double-blind treatment in study 3151A4-327 for fibromyalgia Syndrome with no major protocol violations and no events that would preclude the patient's entry into the long-term open-label study.\n* Women of childbearing potential must have a negative serum pregnancy test result at study start.\n\nExclusion criteria:\n\n* Presence of any new/and or clinically important medical condition that might compromise patient's safety.\n* Use of prohibited treatment.\n* Meets any of the exclusion criteria listed for study 3151A4-327."}, 'identificationModule': {'nctId': 'NCT00424892', 'briefTitle': 'Study Evaluating DVS SR in Patients With Fibromyalgia Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, 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