Trials / Completed
CompletedNCT01271933
Study Of A Controlled Release Formulation Of Pregabalin In Fibromyalgia Patients
A Phase 3 Double-blind, Randomized, Placebo-controlled, Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Fibromyalgia (Protocol A0081245)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 441 (actual)
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy and safety of a controlled release formulation of pregabalin administered once daily as compared to placebo in the treatment of fibromyalgia. All patients will receive pregabalin; half of the patients will receive placebo at some point in the study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | pregabalin | controlled release tablet; 165-495 mg/day; given once daily |
| DRUG | placebo | matching placebo tablet; given once daily |
Timeline
- Start date
- 2011-03-01
- Primary completion
- 2012-07-01
- Completion
- 2012-07-01
- First posted
- 2011-01-07
- Last updated
- 2021-01-22
- Results posted
- 2018-09-14
Locations
52 sites across 4 countries: United States, Canada, India, Taiwan
Source: ClinicalTrials.gov record NCT01271933. Inclusion in this directory is not an endorsement.