A Study For Pregabalin In Patients With Fibromyalgia

• Drug: pregabalin
  
  Pregabalin capsule, 300-450mg/day, twice daily
• Drug: placebo
  
  Placebo, twice daily

• Experimental: Pregabalin
  
  Intervention: Drug: pregabalin
• Placebo Comparator: Placebo
  
  Matched placebo
  Intervention: Drug: placebo

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)