A Controlled Pregabalin Trial In Fibromyalgia

Phase 3

Completed

• Conditions: Fibromyalgia

• Registration Number: NCT00230776
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-09-29
• Study First Submitted QC: 2005-09-29
• Study Start: 2005-10
• Study First Posted: 2005-10-03
• Study Completion: 2006-07
• Status Verified: 2012-10
• Last Update Submitted: 2021-01-22
• Last Update Posted: 2021-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 740

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Milwaukee, Wisconsin, United States