Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-30 @ 9:26 PM
Study NCT ID:
NCT01226667
Status:
COMPLETED
Last Update Posted:
2012-07-31
First Post:
2010-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fixed Versus Flexible Dosing of Pregabalin in Patients With Fibromyalgia
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': 'D000069583', 'term': 'Pregabalin'}], 'ancestors': [{'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 174}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-30', 'studyFirstSubmitDate': '2010-10-01', 'studyFirstSubmitQcDate': '2010-10-20', 'lastUpdatePostDateStruct': {'date': '2012-07-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain score evaluation by NRS', 'timeFrame': '8 weeks', 'description': 'Least square mean change in Fibromyalgia pain at 8weeks compared to baseline utilizing an 11 point numerical rating scale daily pain diary (0 = no pain to 10 =worst possible pain) performed at daily awakening.'}], 'secondaryOutcomes': [{'measure': 'Patient Global Impression of Change', 'timeFrame': 'At weeks 4 and 8'}, {'measure': 'Discontinuation rate', 'timeFrame': '9 weeks', 'description': 'Discontinuation rates due to lack of efficacy and discontinuation rates due to adverse event.'}, {'measure': 'Improvements in Wolfe Symptom Severity Score', 'timeFrame': '9 weeks', 'description': 'Wolfe Symptom Severity scales for pain, fatigue, trouble sleeping, trouble with anxiety or depression, trouble thinking or remembering, overall FM severity, problems awaking feeling unrefreshed'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['fibromyalgia', 'lyrica', 'pregabalin'], 'conditions': ['Fibromyalgia']}, 'referencesModule': {'references': [{'pmid': '23983064', 'type': 'DERIVED', 'citation': 'Nasser K, Kivitz AJ, Maricic MJ, Silver DS, Silverman SL. Twice daily versus once nightly dosing of pregabalin for fibromyalgia: a double-blind randomized clinical trial of efficacy and safety. Arthritis Care Res (Hoboken). 2014 Feb;66(2):293-300. doi: 10.1002/acr.22111.'}]}, 'descriptionModule': {'briefSummary': 'A 9-week randomized double-blind, multi-center study of 172 patients, who after 1 week baseline evaluation are randomized to either fixed dose pregabalin starting at 75 mg BID for one week and increased to 150 mg BID for 7 weeks or flexibly dosed pregabalin given BID (75-300 mg/d) increased gradually over 4 weeks then maintained at that same dosing for 4 weeks.It is proposed that use of flexible dosing combined with nightly dosing would have similar pain relief to fixed dosing, would improve adherence, would have less side effects and would be more likely to improve sleep.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of fibromyalgia by ACR criteria\n* ambulatory patients\n* complete of 5 pain diaries during 1 week evaluation\n* other inclusion criteria may apply\n\nExclusion Criteria:\n\n* pregnant or of childbearing potential not using contraceptives\n* use of pregabalin in the past\n* concomitant use of opioids or gabapentin\n* estimated creatinine clearance less than 60\n* other criteria may apply'}, 'identificationModule': {'nctId': 'NCT01226667', 'acronym': 'Flexdose', 'briefTitle': 'Fixed Versus Flexible Dosing of Pregabalin in Patients With Fibromyalgia', 'organization': {'class': 'OTHER', 'fullName': 'Osteoporosis Medical Center, Beverly Hills, CA'}, 'officialTitle': 'Fixed Versus Flexible Dosing of Pregabalin in Patients With Fibromyalgia', 'orgStudyIdInfo': {'id': 'SLS2009001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Flexible Dose', 'description': 'flexibly dosed pregabalin given BID (75-300 mg/d) increased gradually over 4 weeks then maintained at that same dosing for 4 weeks', 'interventionNames': ['Drug: Pregabalin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fixed Dosing', 'description': '75 mg BID for one week and increased to 150 mg BID for 7 weeks', 'interventionNames': ['Drug: Pregabalin']}], 'interventions': [{'name': 'Pregabalin', 'type': 'DRUG', 'description': 'Fixed dosing of pregabalin: Week 1: 75 mg bid. Weeks 2 - 8: 150 mg bid. Week 9 (Days 57-60 and Days 61-63): 75 mg bid.\n\nFlexible dosing of pregabalin: Week 1: placebo in the AM and 75 mg nightly; Week 2: placebo in the AM and 150 mg nightly.; Week 3 placebo in the a.m., 225 mg nightly; Weeks 4 - 8 placebo in the a.m., 300 mg nightly. Week 9 (Days 57-60) placebo in the a.m,, 150 mg bid nightly and Days 61-63: placebo in the a.m., and 75 mg bid nightly.', 'armGroupLabels': ['Fixed Dosing', 'Flexible Dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'David Silver MD Inc', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Stuart L Silverman MD Inc.', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '92646', 'city': 'Huntington Beach', 'state': 'California', 'country': 'United States', 'facility': 'Talbert Medical Group', 'geoPoint': {'lat': 33.6603, 'lon': -117.99923}}, {'zip': '85704', 'city': 'Tucson', 'state': 'California', 'country': 'United States', 'facility': 'Catalina Pointe Clinial Research'}, {'zip': '91307', 'city': 'West Hills', 'state': 'California', 'country': 'United States', 'facility': 'Affilaites in Medical Specialty', 'geoPoint': {'lat': 34.19731, 'lon': -118.64398}}], 'overallOfficials': [{'name': 'Keaton Nasser', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Osteoporosis Medical Center'}, {'name': 'Stuart L Silverman, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Osteoporosis Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Osteoporosis Medical Center, Beverly Hills, CA', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}