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

Phase 2 Completed 421 enrolled XenoPort, Inc.

RandomizedParallel-groupTriple-blindTreatment

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)

Timeline

Start: 2008-03
Primary completion: 2009-02
Completion: 2009-02

Outcome

Missed primary endpoint

registry Placebo vs GEn 1200 mg/Day; p = 0.295; Adjusted mean difference versus placebo -0.35 (95% CI -1.02 to 0.31); ANCOVA NCT00643760 ↗

registry Placebo vs GEn 2400 mg/Day; p = 0.946; Adjusted mean difference versus placebo -0.02 (95% CI -0.71 to 0.66); ANCOVA NCT00643760 ↗

registry Placebo vs GEn 3600 mg/Day; p = 0.105; Adjusted mean difference versus placebo -0.55 (95% CI -1.10 to 0.01); ANCOVA NCT00643760 ↗

paper Overall, none of the GEn treatment groups differentiated from placebo. PMID 23186035 ↗

Publications

Rauck R, Makumi CW, Schwartz S, Graff O, Meno-Tetang G, Bell CF, Kavanagh ST, McClung CL. A randomized, controlled trial of gabapentin enacarbil in subjects with neuropathic pain associated with diabetic peripheral neuropathy. Pain Pract. 2013 Jul;13(6):485-96. doi: 10.1111/papr.12014. Epub 2012 Nov 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pregabalin	Small molecule	300 mg	Oral
Subject	gabapentin enacarbil	Small molecule	1200 mg	Oral
Subject	gabapentin enacarbil	Small molecule	2400 mg	Oral
Subject	gabapentin enacarbil	Small molecule	3600 mg	Oral