NCT00643760

A Study In Patients With Neuropathic Pain From Diabetic Peripheral Neuropathy (DPN)

Study PXN110448: A Dose-response Study of XP13512, Compared With Concurrent Placebo Control and LYRICA(Pregabalin), in Subjects With Neuropathic Pain Associated Withdiabetic Peripheral Neuropathy (DPN)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 421 (actual)
• Sponsor: XenoPort, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Neuropathy, Diabetic

Interventions

Type	Name	Description
DRUG	Placebo	placebo
DRUG	GEn 1200mg/day	gabapentin enacarbil 1200mg/day
DRUG	GEn 2400mg/day	gabapentin enacarbil 2400mg/day
DRUG	GEn 3600mg/day	gabapentin enacarbil 3600mg/day
DRUG	Pregabalin	pregabalin 300mg/day

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2008-03-26
• Last updated: 2013-07-22
• Results posted: 2011-05-11

Locations

90 sites across 1 country: United States