drugset / Trial / NCT00619476

A Study In Patients With Neuropathic Pain From Post-Herpetic Neuralgia (PHN)

NCT00619476 ↗

Phase 2 Completed 376 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 post-herpetic neuralgia (PHN).

Timeline

Start
2008-02
Primary completion
2009-07
Completion
2009-07

Outcome

Met primary endpoint

registry Placebo vs GEn 1200 mg/Day; p = 0.013; Adjusted Mean difference versus placebo -0.81 (95% CI -1.40 to -0.23) NCT00619476 ↗

registry Placebo vs GEn 2400 mg/Day; p = 0.029; Adjusted Mean difference versus placebo -0.70 (95% CI -1.33 to -0.07) NCT00619476 ↗

registry Placebo vs GEn 3600 mg/Day; p = 0.002; Adjusted Mean difference versus placebo -1.07 (95% CI -1.68 to -0.45) NCT00619476 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject gabapentin enacarbil Small molecule 1200 mg —
Subject gabapentin enacarbil Small molecule 2400 mg —
Subject gabapentin enacarbil Small molecule 3600 mg —