An Open-Label Trial of Pregabalin in Patients With Fibromyalgia
Phase 3
Completed
- Conditions
- Fibromyalgia
- Registration Number
- NCT00151528
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Brief Summary
The main purpose of this protocol is to evaluate the long-term safety of pregabalin in patients who participated in the previous fibromyalgia Study A0081056 and who wish to receive open-label pregabalin therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 428
Inclusion Criteria
- Patients must have met the inclusion criteria for the preceding fibromyalgia Protocol A0081056
- Must have received pregabalin/placebo under double-blind conditions.
Exclusion Criteria
- Patients may not participate in the study if they experienced a serious adverse event during the previous fibromyalgia Study A0081056 which was determined to be related to the study medication by the investigator or the sponsor.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Main outcome of the study is long-term safety of pregabalin in patients with fibromyalgia. This is a 1 year open-label extension of the preceding double-blind randomized fibromyalgia protocol A0081056.
- Secondary Outcome Measures
Name Time Method There are no secondary outcome measures
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Yakima, Washington, United States
Pfizer Investigational Site🇺🇸Yakima, Washington, United States