Trials / Completed
CompletedNCT00830167
Randomized, Double-Blind, Placebo-Controlled Study Of Pregabalin In Patients With Fibromyalgia
Randomized, Double-Blind, Multicenter, Placebo-Controlled Study To Evaluate Efficacy And Safety Of Pregabalin（CI-1008）In The Treatment Of Fibromyalgia
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 498 (actual)
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study, will compare pregabalin with placebo for the duration of 15 weeks to evaluate the efficacy and safety of pregabalin in patients with fibromyalgia.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | Dosage: placebo, oral administration, Treatment duration: 15 weeks (3-week titration and 12-week fixed dose) |
| DRUG | Pregabalin | Dosage: 300 or 450 mg/day (150 or 225 mg bid), oral administration, Treatment duration: 15 weeks (3-week titration and 12-week fixed dose) |
Timeline
- Start date
- 2009-03-01
- Primary completion
- 2011-05-01
- Completion
- 2011-05-01
- First posted
- 2009-01-27
- Last updated
- 2021-01-25
- Results posted
- 2012-06-01
Locations
35 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT00830167. Inclusion in this directory is not an endorsement.