Status:
COMPLETED
Fixed Versus Flexible Dosing of Pregabalin in Patients With Fibromyalgia
Lead Sponsor:
Osteoporosis Medical Center, Beverly Hills, CA
Collaborating Sponsors:
Pfizer
Conditions:
Fibromyalgia
Eligibility:
FEMALE
18-65 years
Phase:
PHASE4
Brief Summary
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 increas...
Eligibility Criteria
Inclusion
- diagnosis of fibromyalgia by ACR criteria
- ambulatory patients
- complete of 5 pain diaries during 1 week evaluation
- other inclusion criteria may apply
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT01226667
Start Date
July 1 2010
End Date
July 1 2012
Last Update
July 31 2012
Active Locations (5)
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1
David Silver MD Inc
Beverly Hills, California, United States, 90211
2
Stuart L Silverman MD Inc.
Beverly Hills, California, United States, 90211
3
Talbert Medical Group
Huntington Beach, California, United States, 92646
4
Catalina Pointe Clinial Research
Tucson, California, United States, 85704