A 14-Week, Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin Twice Daily In Patients With Fibromyalgia

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 site in 1 country740 target enrollmentOctober 2005

ConditionsFibromyalgia

Drugspregabalin placebo

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Fibromyalgia
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Enrollment: 740
Locations: 1
Primary Endpoint: To evaluate the efficacy of pregabalin for pain relief by comparing the mean pain score between treatment groups and placebo.
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To evaluate the efficacy and safety of pregabalin compared with placebo for the relief of pain associated with fibromyalgia and improvement of function of patients with fibromyalgia

Registry

clinicaltrials.gov

Start Date

October 2005

End Date

July 2006

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

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

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients must meet the 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 must have a score of \>40 mm on the Visual Analog Scale

Exclusion Criteria

•Patients with any widespread inflammatory musculoskeletal disorders, widespread rheumatic diseases other than fibromyalgia, active infections, or untreated endocrine disorders.

Outcomes

Primary Outcomes

To evaluate the efficacy of pregabalin for pain relief by comparing the mean pain score between treatment groups and placebo.

Secondary Outcomes

To evaluate the efficacy of pregabalin for improvement in sleep, fatigue, health-related quality of life, functioning and mood disturbance associated with fibromyalgia. To evaluate safety and tolerability.