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

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

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

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.