A Study of the Efficacy and Safety of Pregabalin for the Treatment of Fibromyalgia

Completed · Phase 3 · Has a placebo group

Conditions studied: Fibromyalgia

In brief

The purpose of this study is to evaluate the efficacy and safety of pregabalin versus placebo for the symptomatic relief of pain associated with fibromyalgia. If this objective is met, then the second objective will be to evaluate the efficacy and safety of pregabalin versus placebo for the management of fibromyalgia (pain, patient global assessment, and functional status). Additionally, the study will evaluate the efficacy of pregabalin versus placebo to improve sleep, fatigue, and mood disturbance associated with fibromyalgia.

Key facts

Study ID

NCT00645398

Run by

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

People needed

751

Starts

2004-09-01

Expected to finish

2005-06-01

Last updated by the study team

2021-01-25

Who can join

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

You may qualify if…

• Patients who met the American College of Rheumatology (ACR) criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites)
• Patients who completed at least 4 pain diaries within the last 7 days and the average pain score must have been ≥4, and had a score of ≥40 mm on the Visual Analogue Scale (VAS) of the SF-MPQ at screening (Visit 1) and randomization (Visit 2)

You may not qualify if…

• Patients with other severe pain that may confound assessment or self-evaluation of the pain associated with fibromyalgia
• Patients with any inflammatory muscle or rheumatologic disease other than fibromyalgia, active infections, or untreated endocrine disorders
• Patients with severe depression

Where it is running

• Pfizer Investigational Site — Huntsville, Alabama, United States
• Pfizer Investigational Site — Paradise Valley, Arizona, 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 — Hot Springs, Arkansas, United States
• Pfizer Investigational Site — Little Rock, Arkansas, United States
• Pfizer Investigational Site — Beverly Hills, California, United States
• Pfizer Investigational Site — Long Beach, California, United States
• Pfizer Investigational Site — Los Alamitos, California, United States
• Pfizer Investigational Site — Newport Beach, California, United States
• Pfizer Investigational Site — Northridge, California, United States
• Pfizer Investigational Site — Northridge, California, United States
• Pfizer Investigational Site — Pismo Beach, California, United States
• Pfizer Investigational Site — Redondo Beach, California, United States
• Pfizer Investigational Site — Riverside, California, United States
• Pfizer Investigational Site — Riverside, California, United States
• Pfizer Investigational Site — Walnut Creek, California, United States
• Pfizer Investigational Site — Whittier, California, United States
• Pfizer Investigational Site — Danbury, Connecticut, United States
• Pfizer Investigational Site — New Milford, Connecticut, United States
• Pfizer Investigational Site — Stratford, Connecticut, United States
• Pfizer Investigational Site — Clearwater, Florida, United States
• Pfizer Investigational Site — Miami, Florida, United States
• Pfizer Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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