Safety and Efficacy Study of Pregabalin in Fibromyalgia

Completed · Phase 3 · Has a placebo group

Conditions studied: Fibromyalgia

In brief

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.

Key facts

Study ID

NCT00151489

Run by

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

People needed

1020

Starts

2005-04-01

Expected to finish

2006-06-01

Last updated by the study team

2021-01-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Pfizer Investigational Site — Birmingham, Alabama, United States
• Pfizer Investigational Site — Calera, Alabama, United States
• Pfizer Investigational Site — Huntsville, Alabama, United States
• Pfizer Investigational Site — Tuscaloosa, Alabama, United States
• Pfizer Investigational Site — Phoenix, Arizona, United States
• Pfizer Investigational Site — Phoenix, Arizona, United States
• Pfizer Investigational Site — Scottsdale, Arizona, United States
• Pfizer Investigational Site — Fayetteville, Arkansas, United States
• Pfizer Investigational Site — Hot Springs, Arkansas, United States
• Pfizer Investigational Site — Anaheim, California, United States
• Pfizer Investigational Site — Carmichael, California, United States
• Pfizer Investigational Site — Fresno, California, United States
• Pfizer Investigational Site — Los Alamitos, California, United States
• Pfizer Investigational Site — Northridge, California, United States
• Pfizer Investigational Site — Pismo Beach, California, United States
• Pfizer Investigational Site — Santa Ana, California, United States
• Pfizer Investigational Site — Walnut Creek, California, United States
• Pfizer Investigational Site — Whittier, California, United States
• Pfizer Investigational Site — Denver, Colorado, United States
• Pfizer Investigational Site — Stratford, Connecticut, United States
• Pfizer Investigational Site — Newark, Delaware, United States
• Pfizer Investigational Site — Washington D.C., District of Columbia, United States
• Pfizer Investigational Site — Chiefland, Florida, United States
• Pfizer Investigational Site — Clearwater, Florida, United States
• Pfizer Investigational Site — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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