Neuralgia,Postherpetic Clinical Trial
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
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.
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).
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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