Conditions: Pain Diabetic Peripheral Neuropathy
Keywords: Pain Diabetic Peripheral Neuropathy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 450
Healthy volunteers: no

Brief summary:
The purpose of this study is to investigate the effectiveness and safety of DS-5565, compared to placebo, in subjects with pain associated with diabetic peripheral neuropathy.

Detailed description:

Arms:
arm 1: DS-5565 10mg/day, administered in 2 doses. Treatment period: 1 week titration and 6 weeks of fixed dose. arm 2: DS-5565 20mg/day, administered in 2 doses. Treatment period: 1 week titration and 6 weeks of fixed dose. arm 3: DS-5565 30mg/day, administered in 2 doses. Treatment period: 1 week titration and 6 weeks of fixed dose. arm 4: DS-5565 placebo oral tablets and pregabalin placebo oral capsules administered 2 times per day. arm 5: Pregabalin capsules 300mg/day administered in 2 doses

Interventions: intervention 1: DS-5565 intervention 2: DS-5565 intervention 3: DS-5565 intervention 4: Placebo intervention 5: Pregabalin capsules
Intervention descriptions: intervention 1: Oral tablets administered twice daily intervention 2: Oral tablets administered twice daily intervention 3: Oral tablets administered twice daily intervention 4: DS-5565 placebo oral tablets and pregabalin placebo oral capsules administered 2 times per day intervention 5: Pregabalin oral capsules 150 mg administered twice a day

Protocol document: