A Safety Study Of Pregabalin In Fibromyalgia

Phase 3

Completed

• Conditions: Fibromyalgia

• Registration Number: NCT00282997
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

To evaluate the safety of pregabalin in patients with fibromyalgia.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-01-26
• Study First Submitted QC: 2006-01-26
• Study First Posted: 2006-01-27
• Study Start: 2006-02
• Study Completion: 2006-10
• Status Verified: 2007-10
• Last Update Submitted: 2021-01-21
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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 complete the double-blind study.

Exclusion Criteria

• Patients who experienced a serious adverse event during the previous fibromyalgia study, which was determined to be related to the study medication.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To evaluate the safety of pregabalin in patients with fibromyalgia

Trial Locations

Locations (1)

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