Fixed Versus Flexible Dosing of Pregabalin in Patients With Fibromyalgia
Completed · Phase 4 · Has a placebo group
Conditions studied: Fibromyalgia
In brief
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.
Key facts
- Study ID
- NCT01226667
- Run by
- Osteoporosis Medical Center, Beverly Hills, CA
- People needed
- 174
- Starts
- 2010-07-01
- Expected to finish
- 2012-07-01
- Last updated by the study team
- 2012-07-31
Who can join
Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- diagnosis of fibromyalgia by ACR criteria
- ambulatory patients
- complete of 5 pain diaries during 1 week evaluation
- other inclusion criteria may apply
You may not qualify if…
- 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
Where it is running
- 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, United States
Full record on ClinicalTrials.gov
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