Safety and Efficacy Study of Pregabalin in Fibromyalgia

Inclusion Criteria:

• At screening (V1), patients must meet the American College of Rheumatology criteria for fibromyalgia (i.e. widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites
• At Screen (V1) and enrollment (V2), patients must have a score of greater than 40 mm on the Pain Visual Analog Scale

Exclusion Criteria:

• Other severe pain or inflammatory muscle or rheumatologic disease other than fibromyalgia, active infections or untreated endocrine disorders; or severe depression and other serious hepatic, respiratory, hematologic or immunologic illness or active malignancy or history of malignancy (examples of prohibited diseases: Hepatitis C, HIV, diabetes with nerve pain, other nerve pain (shingles), sleep apnea, epilepsy, narcolepsy, rheumatoid arthritis, generalized osteoarthritis, Lupus, Lyme disease unless sign and symptom free for 2 years, Sjogren's Syndrome, Sarcoid, Psoriatic Arthritis, Scleroderma)
• Previous participation in a clinical trial with pregabalin; currently receiving or pending disability claims or workmans compensation or civil litigation, or used other experimental medicines within 30 days of screening
• Creatinine Clearance less than 60 mL/min (estimated from serum creatinine; low platelet and/or white blood cell counts; abnormal Westergren erythrocyte sedimentation rate; abnormal antinuclear antibody (ANA greater than 3U), or rheumatoid factor (RF greater than 80 IU/mL); abnormal (clinically relevant 12 lead ECG)
• Use of prohibited pain/sleep medications (including antidepressants, sedatives, hypnotics, NSAIDs, opiates, muscle relaxants) during the study. Washout required prior to study entry.