Conditions: Fibromyalgia
Keywords: fibromyalgia pain pregabalin Lyrica
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 441
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: pregabalin intervention 2: placebo
Intervention descriptions: intervention 1: controlled release tablet; 165-495 mg/day; given once daily intervention 2: matching placebo tablet; given once daily

Protocol document: