NCT00645398

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

A 13-week, Randomized, Double-Blind, Placebo-Controlled, Monotherapy Trial of Pregabalin (BID) in Patients With Fibromyalgia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 751 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Fibromyalgia

Interventions

Type	Name	Description
DRUG	Pregabalin	Pregabalin 225 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
DRUG	Pregabalin	Pregabalin 150 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
DRUG	Pregabalin	Pregabalin 300 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
DRUG	Placebo	Matching placebo capsules taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).

Timeline

• Start date: 2004-09-01
• Completion: 2005-06-01
• First posted: 2008-03-27
• Last updated: 2021-01-25

Locations

102 sites across 1 country: United States