Conditions: Neuralgia,Postherpetic
Keywords: Postherpetic Neuralgia (PHN), shingles
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 452
Healthy volunteers: no

Brief 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).

Arms:
arm 1: Gabapentin - Extended Release arm 2: Sugar pill

Interventions: intervention 1: Gabapentin Extended Release tablets intervention 2: Placebo
Intervention descriptions: intervention 1: Once-Daily; 300 mg and 600 mg tablets intervention 2: Once daily; 300 mg and 600 mg tablets

Protocol document: