Conditions: Pain Associated With Fibromyalgia
Keywords: pain fibromyalgia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1293
Healthy volunteers: no

Brief summary:
The main objective of this trial is to compare change in weekly average daily pain score (ADPS) from baseline to Week 13 in subjects receiving either dose of DS-5565 versus placebo. Weekly ADPS is based on daily pain scores reported by the participant that best describes his or her worst pain over the previous 24 hours.

Detailed description:

Arms:
arm 1: Participants take one each of placebo tablet and capsule in the morning, and one DS-5565 tablet once daily (QD) with a placebo capsule in the evening arm 2: Participants take one DS-5565 tablet and one placebo capsule, twice daily (BID) arm 3: Participants take one pregabalin capsule and one placebo tablet BID arm 4: Participants take one each of placebo tablet and capsule BID

Interventions: intervention 1: DS-5565 intervention 2: Pregabalin intervention 3: Placebo tablet intervention 4: Placebo capsule
Intervention descriptions: intervention 1: DS-5565 15 mg tablet for oral administration intervention 2: Pregabalin 150 mg capsule for oral administration intervention 3: Placebo tablet (matching DS-5565) for oral administration intervention 4: Placebo capsule (matching pregabalin) for oral administration

Protocol document: