- 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
- 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)