A Clinical Study in Subjects With Neuropathic Pain From PHN Who Have Had an Inadequate Response to Gabapentin Treatment

Summary

The purpose of this study is evaluate the difference between two doses of gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, on pain associated with post-herpetic neuralgia.

Timeline

Start

2008-03

Primary completion

2009-07

Completion

2009-07

Outcome

Met primary endpoint

registry analysis (superiority or other test); GEn 1200 mg vs GEn 3600 mg; p = 0.013 NCT00617461 ↗

paper with GEn 3,600 mg vs 1,200 mg (adjusted mean [90% confidence interval] treatment difference, -0.29 [-0.48 to -0.10]; P = 0.013). PMID 24102928 ↗

Publications

• Harden RN, Freeman R, Rainka M, Zhang L, Bell C, Berges A, Chen C, Graff O, Harding K, Hunter S, Kavanagh S, Schwartzbach C, Warren S, McClung C. A phase 2a, randomized, crossover trial of gabapentin enacarbil for the treatment of postherpetic neuralgia in gabapentin inadequate responders. Pain Med. 2013 Dec;14(12):1918-32. doi: 10.1111/pme.12227. Epub 2013 Sep 18.

Drugs

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

Indications