Safety and Efficacy Study of Pregabalin in Fibromyalgia

Viatris

Status and phase

Completed

Phase 3

Conditions

Fibromyalgia

Treatments

Drug: pregabalin

Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00151489

A0081059

Details and patient eligibility

About

The purpose of this research study of pregabalin and fibromyalgia is to see if 1. pregabalin reduces the pain of fibromyalgia and if this effect lasts for six months and 2. to see if different dosages work better (reduce pain and mild to no side effects) for different people.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.