Conditions: Neuropathy, Diabetic
Keywords: Peripheral Diabetic Neuropathy (PDN) Neuropathic Pain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 421
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine whether gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn is effective in the treatment of neuropathic pain associated with diabetic peripheral neuropathy(DPN)

Detailed description:
This is a dose-response study of XP13512 compared with concurrent placebo control and LYRICA (pregabalin), in subjects with neuropathic pain associated with DPN. Three doses of XP13512 (1200 mg/day, 2400 mg/day and 3600 mg/day) are being evaluated for the management of neuropathic pain associated with DPN. Approximately 392 subjects from 70 to 80 participating sites in the US will be randomized to receive either XP13512 at the above mentioned doses, placebo or pregabalin (300mg/day).

Arms:
arm 1: Placebo arm 2: Pregabalin 300mg/day (positive control), maintenance treatment 14 weeks arm 3: gabapentin enacarbil 1200mg/day, maintenance treatment 14 weeks arm 4: gabapentin enacarbil 2400mg/day, maintenance treatment 14 weeks arm 5: gabapentin enacarbil 3600mg/day, maintanance treatment 14 weeks

Interventions: intervention 1: Placebo intervention 2: GEn 1200mg/day intervention 3: GEn 2400mg/day intervention 4: GEn 3600mg/day intervention 5: Pregabalin
Intervention descriptions: intervention 1: placebo intervention 2: gabapentin enacarbil 1200mg/day intervention 3: gabapentin enacarbil 2400mg/day intervention 4: gabapentin enacarbil 3600mg/day intervention 5: pregabalin 300mg/day

Protocol document: