A Study For Pregabalin In Patients With Fibromyalgia

• Status: Completed
• Trial end date: 2016-10-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and tolerability of pregabalin compared with placebo for management of fibromyalgia in adults.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer; Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Treatments: Pregabalin

Criteria

Inclusion Criteria:

• Male or female patients, at least 18 years of age

• Meeting the ACR (America College of Rheumatology) criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites)

• At screening (V1) and randomization (V2), patients must have a score of no less than 40 mm on the Pain Visual Analog Scale (VAS)

• At randomization (V2), at least 4 pain diaries must be completed satisfactorily within the last 7 days and the average pain score must be no less than 4

Exclusion Criteria:

• Patients with no less than 30% decrease on the Pain Visual Analog Scale (VAS) at randomization (V2) as compared to screening (V1)

• Patients with other severe pain due to other conditions (eg, DPN or PHN) that may confound assessment or self-evaluation of the pain associated with fibromyalgia

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

• CLcr less than 60 mL/min (estimated from serum creatinine)