Conditions: Fibromyalgia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 125
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate if DVS SR is safe and effective in the treatment of pain associated with fibromyalgia syndrome, and if so to identify the efficacious doses.

Detailed description:

Arms:
arm 1: In the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor. arm 2: In the first stage, subjects were randomly assigned to receive DVS SR 200 mg/day. Study was stopped after stage 1 by sponsor. arm 3: In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor.

Interventions: intervention 1: Desvenlafaxine Sustained Release (DVS SR) intervention 2: Lyrica® (Pregabalin) intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: