Fibromyalgia Clinical Trial
— FlexdoseOfficial title:
Fixed Versus Flexible Dosing of Pregabalin in Patients With Fibromyalgia
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.
Status | Completed |
Enrollment | 174 |
Est. completion date | July 2012 |
Est. primary completion date | July 2012 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - diagnosis of fibromyalgia by ACR criteria - ambulatory patients - complete of 5 pain diaries during 1 week evaluation - other inclusion criteria may apply Exclusion Criteria: - pregnant or of childbearing potential not using contraceptives - use of pregabalin in the past - concomitant use of opioids or gabapentin - estimated creatinine clearance less than 60 - other criteria may apply |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | David Silver MD Inc | Beverly Hills | California |
United States | Stuart L Silverman MD Inc. | Beverly Hills | California |
United States | Talbert Medical Group | Huntington Beach | California |
United States | Catalina Pointe Clinial Research | Tucson | California |
United States | Affilaites in Medical Specialty | West Hills | California |
Lead Sponsor | Collaborator |
---|---|
Osteoporosis Medical Center, Beverly Hills, CA | Pfizer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain score evaluation by NRS | 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. | 8 weeks | No |
Secondary | Patient Global Impression of Change | At weeks 4 and 8 | No | |
Secondary | Discontinuation rate | Discontinuation rates due to lack of efficacy and discontinuation rates due to adverse event. | 9 weeks | Yes |
Secondary | Improvements in Wolfe Symptom Severity Score | 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 | 9 weeks | No |
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