Ignite Creation Date:
2025-12-25 @ 2:26 AM
Ignite Modification Date:
2025-12-30 @ 2:51 PM
Study NCT ID:
NCT00346034
Status:
COMPLETED
Last Update Posted:
2021-01-22
First Post:
2006-06-28
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
This Study is An Open-Label Trial Of Pregabalin In Patients With Fibromyalgia
Sponsor:
Organization:
Raw JSON
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Investigator will postpone single center publications until after disclosure of pooled data (all sites), \\<12 mo from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Pregabalin', 'description': 'Subjects began the open-label study (A0081101) medication the morning after termination visit from double-blind study (A0081100) at a fixed dose of 300 mg/day. Pregabalin daily dose was adjusted thereafter by the investigator to optimize pain control and to minimize adverse events. Adjustments to total daily doses were permitted for the remainder of the study. 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{'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA (v11.1)'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to Week 4 in Pain Visual Analog Scale (VAS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregabalin', 'description': 'Subjects began the open-label study (A0081101) medication the morning after termination visit from double-blind study (A0081100) at a fixed dose of 300 mg/day. 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Adjustments to total daily doses were permitted for the remainder of the study. The minimum permissible daily dose was 150 mg/day (75 mg BID) and the maximum daily dose was 600 mg/day (300 mg BID) of pregabalin.'}], 'classes': [{'categories': [{'measurements': [{'value': '-20.1', 'spread': '26.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12 (end of treatment)', 'description': 'Mean Change: Observation VAS score minus Baseline score. Pain VAS is a 100mm horizontal line used to rate (score) pain by subject from 0 "no pain" to 100 "worst possible pain". Baseline=value @ double-blind screening if randomized to pregabalin during double-blind OR value @ last visit from double-blind if randomized to placebo during double-blind.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This will include all patients who have received at least one dose of study medication and observations at both baseline and week 12.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pregabalin', 'description': 'Subjects began the open-label study (A0081101) medication the morning after termination visit from double-blind study (A0081100) at a fixed dose of 300 mg/day. Pregabalin daily dose was adjusted thereafter by the investigator to optimize pain control and to minimize adverse events. Adjustments to total daily doses were permitted for the remainder of the study. The minimum permissible daily dose was 150 mg/day (75 mg BID) and the maximum daily dose was 600 mg/day (300 mg BID) of pregabalin.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '357'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '300'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '34'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'Patient Stopped Taking Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Not Willing to Follow Dosing Regimen', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study was planned to include all eligible subjects continuing from the preceding double-blind study A0081100 NCT00333866 (Subjects had to be at least 18 years old and have met the American College of Rheumatology criteria for fibromyalgia).', 'preAssignmentDetails': 'Following the termination visit in study A0081100, subjects had an option of starting pregabalin under open-label conditions the day after the termination visit.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Pregabalin', 'description': 'Subjects began the open-label study (A0081101) medication the morning after termination visit from double-blind study (A0081100) at a fixed dose of 300 mg/day. Pregabalin daily dose was adjusted thereafter by the investigator to optimize pain control and to minimize adverse events. Adjustments to total daily doses were permitted for the remainder of the study. The minimum permissible daily dose was 150 mg/day (75 mg BID) and the maximum daily dose was 600 mg/day (300 mg BID) of pregabalin.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.3', 'spread': '11.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '322', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 357}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-20', 'studyFirstSubmitDate': '2006-06-28', 'resultsFirstSubmitDate': '2009-02-12', 'studyFirstSubmitQcDate': '2006-06-28', 'lastUpdatePostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-02-12', 'studyFirstPostDateStruct': {'date': '2006-06-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to Week 4 in Pain Visual Analog Scale (VAS) Score', 'timeFrame': 'Week 4', 'description': 'Mean Change: Observation VAS score minus Baseline score. Pain VAS: 100 mm horizontal line to rate (score) pain from 0 "no pain" to 100 "worst possible pain". Baseline = value @ double-blind screening if randomized to pregabalin during double-blind or value @ last visit from double-blind if randomized to placebo during double-blind.'}, {'measure': 'Change From Baseline to Week 12 in Pain Visual Analog Scale (VAS) Score', 'timeFrame': 'Week 12 (end of treatment)', 'description': 'Mean Change: Observation VAS score minus Baseline score. Pain VAS is a 100mm horizontal line used to rate (score) pain by subject from 0 "no pain" to 100 "worst possible pain". Baseline=value @ double-blind screening if randomized to pregabalin during double-blind OR value @ last visit from double-blind if randomized to placebo during double-blind.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Fibromyalgia']}, 'referencesModule': {'references': [{'pmid': '22503162', 'type': 'DERIVED', 'citation': 'Arnold LM, Emir B, Murphy TK, Zeiher BG, Pauer L, Scott G, Petersel D. Safety profile and tolerability of up to 1 year of pregabalin treatment in 3 open-label extension studies in patients with fibromyalgia. Clin Ther. 2012 May;34(5):1092-102. doi: 10.1016/j.clinthera.2012.03.003. Epub 2012 Apr 14.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081101&StudyName=This%20Study%20is%20An%20Open-Label%20Trial%20Of%20Pregabalin%20In%20Patients%20With%20Fibromyalgia%20%20%20', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this protocol is to evaluate the long-term safety of pregabalin in patients who participated in the previous fibromyalgia Study A0081100 and who wish to receive open-label pregabalin therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must have met the inclusion criteria for the preceding fibromyalgia Protocol A0081100, and must have received pregabalin/placebo under double-blind conditions.\n\nExclusion Criteria:\n\n* Patients may not participate in the study if they experienced a serious adverse event during the previous fibromyalgia Study A0081100 which was determined to be related to the study medication by the investigator or the sponsor.'}, 'identificationModule': {'nctId': 'NCT00346034', 'briefTitle': 'This Study is An Open-Label Trial Of Pregabalin In Patients With Fibromyalgia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A 12 Week, Open-Label, Safety Trial Of Pregabalin In Patients With Fibromyalgia', 'orgStudyIdInfo': {'id': 'A0081101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Pregabalin']}], 'interventions': [{'name': 'Pregabalin', 'type': 'DRUG', 'description': '150 to 600mg/day', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V1Y 2H4', 'city': 'Kelowna', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 49.88307, 'lon': -119.48568}}, 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