Conditions: Pain Associated With Fibromyalgia
Keywords: pain fibromyalgia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1301
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 participants receiving either dose of DS-5565 versus placebo.

Weekly ADPS is based on daily pain scores reported by the subject 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, twice daily (BID) arm 2: Participants take one pregabalin capsule and one placebo tablet BID arm 3: Participants take one each of placebo tablet and capsule in the morning and one placebo capsule in the evening with one DS-5565 tablet once daily (QD) arm 4: Participants take one placebo capsule with one DS-5565 tablet 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 QD or BID; tablet for oral use intervention 2: Pregabalin capsule for oral use; 75 mg capsule for one week, then 150 mg capsule intervention 3: Placebo tablet for oral use, matching DS-5565 tablet intervention 4: Placebo capsule for oral use, matching pregabalin capsule

Protocol document: