CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 421 enrolled
Drug / intervention
Placebo +4 moredrug
Likely dose
GEn 1200mg/dayfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00643760
NCT00643760Phase 2Completed
CompareCT.gov

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)

XenoPort, Inc.·interventional·Posted Mar 26, 2008·Updated Jul 22, 2013

In Brief

A Phase 2 clinical trial evaluating Placebo, GEn 1200mg/day, and 3 other interventions for Neuropathy, Diabetic. Completed, enrolled 421 participants across 90 sites.

Detailed 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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeuropathy, Diabetic
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 26, 2008
Enrollment StartMar 1, 2008
Primary CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 18.3 years ago

Interventions

Placebodrug

placebo

GEn 1200mg/daydrug

gabapentin enacarbil 1200mg/day

GEn 2400mg/daydrug

gabapentin enacarbil 2400mg/day

GEn 3600mg/daydrug

gabapentin enacarbil 3600mg/day

Pregabalindrug

pregabalin 300mg/day