Conditions: Diabetic Peripheral Neuropathy
Keywords: Keywords: pain, diabetes, neuropathy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 452
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the safety, tolerability and effectiveness of DS-5565 compared to placebo (inactive substance) and pregabalin in diabetic subjects with DPN.

Detailed description:
Diabetic peripheral neuropathy (DPN) affects up to 50% of patients who have diabetes for at least 25 years. Up to 26% of all patients with DPN experience neuropathic pain. DPN pain contributes to sleep disorders, depression, and anxiety, which together may have an impact on a patient's well-being and quality of life.

There are currently several drugs used to treat painful DPN. For example, Lyrica® (pregabalin) is approved by the United States Food and Drug Administration (FDA) to treat neuropathic pain associated with DPN and is commonly prescribed. The dosage of the FDA-approved drugs is limited by side-effects such as dizziness, sleepiness, weight gain and swelling of the hands, legs, and feet. As a result, many patients suffering from DPN pain do not get satisfactory pain relief.

Arms:
arm 1: DS-5565 5 mg/day (one 5 mg tablet at bedtime) arm 2: DS-5565 10 mg/day (one 10 mg tablet at bedtime) arm 3: DS-5565 15 mg/day (one 5 mg tablet plus one 10 mg tablet at bedtime) arm 4: DS-5565 20 mg/day (one 10 mg tablet in the morning and one 10 mg tablet at bedtime) arm 5: DS-5565 30 mg/day (one 5 mg tablet plus one 10 mg tablet in the morning and one 5 mg tablet plus one 10 mg tablet at bedtime) arm 6: Pregabalin 300 mg/day (two 150 mg capsules, in the morning and at bedtime)

Interventions: intervention 1: DS-5565 tablet intervention 2: pregabalin capsule intervention 3: Placebo tablet intervention 4: placebo capsule
Intervention descriptions: intervention 1: 5mg and 10mg tablets intervention 2: 75mg and 150mg over-encapsulated intervention 3: None intervention 4: None

Protocol document: