NCT00636636

Safety and Efficacy of Gabapentin in Postherpetic Neuralgia

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 452 (actual)
• Sponsor: Depomed · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary study objective is to assess the relative efficacy of G-ER dosed once daily (1800 mg following the evening meal), versus placebo in reducing the mean daily pain score from the baseline week to the end of the efficacy treatment period (Treatment Week 10) in patients with PHN. Secondary efficacy measures will include changes from baseline in mean weekly sleep interference scores, Short-Form McGill Pain Questionnaire (SF-MPQ), the Neuropathic Pain Scale (NPS), Brief Pain Inventory (BPI), Patient Global Impression of Change (PGIC), and Investigator-Rated Clinical Global Impression of Change (CGIC).

Conditions

• Neuralgia,Postherpetic

Interventions

Type	Name	Description
DRUG	Gabapentin Extended Release tablets	Once-Daily; 300 mg and 600 mg tablets
DRUG	Placebo	Once daily; 300 mg and 600 mg tablets

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-08-01
• Completion: 2009-09-01
• First posted: 2008-03-14
• Last updated: 2012-02-22
• Results posted: 2012-01-13

Locations

39 sites across 3 countries: United States, Argentina, Russia