The Efficacy and Safety of Pregabalin Release Tablets for the Treatment of Fibromyalgia

• Status: Unknown status
• Trial end date: 2019-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the Efficacy and safety of pregabalin sustained release tablets versus placebo for fibromyalgia

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

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Treatments: Pregabalin

Criteria

Inclusion Criteria:

• Patients who met the 1990 American College of Rheumatology (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 who completed at least 4 pain diaries within the last 7 days and the average pain score must have been ≥4, and had a score of ≥40 mm on the Visual Analogue Scale (VAS) at screening and randomization .

Exclusion Criteria:

• Patients with other severe pain that may confound assessment or self-evaluation of the pain associated with fibromyalgia.

Patients with any inflammatory muscle or rheumatologic disease other than fibromyalgia, active infections, or untreated endocrine disorders.