CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 452 enrolled
Drug / intervention
Gabapentin Extended Release tablets +1 moredrug
Likely dose
Gabapentin Extended Release tablets 300 mgfrom 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/NCT00636636
NCT00636636Phase 3Completed

A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Gabapentin Extended Release (G-ER) Tablets in the Treatment of Patients With Postherpetic Neuralgia

Depomed·interventional·Posted Mar 14, 2008·Updated Feb 22, 2012

In Brief

A Phase 3 clinical trial evaluating Gabapentin Extended Release tablets and Placebo for Neuralgia,Postherpetic. Completed, enrolled 452 participants across 39 sites in 3 countries.

Detailed Summary

Gabapentin and pregabalin are treatments for some types of neuropathic pain, including postherpetic neuralgia (PHN). However, these treatments usually need to be taken 3 times a day for effective pain control. The purpose of this study is to determine whether a new gabapentin tablet, which only needs to be taken once a day, is safe and effective for the treatment of postherpetic neuralgia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Russia, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 14, 2008
Enrollment StartMar 1, 2008
Primary CompletionAug 1, 2009
Study CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 18.3 years ago

Interventions

Gabapentin Extended Release tabletsdrug

Once-Daily; 300 mg and 600 mg tablets

Placebodrug

Once daily; 300 mg and 600 mg tablets