Safety and Efficacy of Gabapentin in Postherpetic Neuralgia
|ClinicalTrials.gov Identifier: NCT00335933|
Recruitment Status : Completed
First Posted : June 12, 2006
Last Update Posted : August 2, 2007
|Condition or disease||Intervention/treatment||Phase|
|Neuralgia, Postherpetic||Drug: Gabapentin extended-release tablets||Phase 3|
The primary study objective is to assess the relative efficacy of G-ER dosed once daily (1800 mg following the evening meal) or twice daily (600 mg AM/1200 mg PM), 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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||378 participants|
|Intervention Model:||Factorial Assignment|
|Official Title:||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|
|Study Start Date :||May 2006|
|Actual Study Completion Date :||July 2007|
- The primary study objective is to assess the relative efficacy of G-ER versus placebo in reducing the average daily pain score from the baseline week to the final week of the efficacy treatment period (Treatment Week 10) in patients with PHN
- Daily pain scores will be measured using an electronic diary.
- Secondary objectives include assessment of changes from baseline in average daily sleep interference scores.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00335933
|United States, Texas|
|Austin, Texas, United States, 78704|
|Study Director:||Bret Berner, Ph.D.||Sponsor/Depomed, Inc.|