Conditions: Fibromyalgia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 211
Healthy volunteers: no

Brief summary:
This study will explore the safety and effectiveness of different doses of AGN 203818 in treating the pain associated with fibromyalgia syndrome. The study is being conducted in 2 parts. Part A enrolled 211 pts dosed with either 3, 20, 60 mg BID AGN 203818 or placebo over 4 week treatment duration. Part B will enroll 440 pts and dose with either 20, 100, 160 mg BID AGN 203818 or placebo over 12 week treatment duration.

Detailed description:

Arms:
arm 1: Part A: Placebo every 12 hours for 4 weeks arm 2: Part A: 3 mg AGN 203818 every 12 hours for 4 weeks arm 3: Part A: 20 mg AGN 203818 every 12 hours for 4 weeks arm 4: Part A: 60 mg AGN 203818 every 12 hours for 4 weeks

Interventions: intervention 1: placebo intervention 2: AGN 203818 intervention 3: AGN 203818 intervention 4: AGN 203818
Intervention descriptions: intervention 1: Part A: Placebo every 12 hours for 4 weeks intervention 2: Part A: AGN 203818 3 mg every 12 hours for 4 weeks intervention 3: Part A: AGN 203818 20 mg every 12 hours for 4 weeks intervention 4: Part A: AGN 203818 60 mg every 12 hours for 4 weeks

Protocol document: