Evaluation of Civamide Patch in Treatment of Postherpetic Neuralgia and Post-Incisional Neuralgia

Postherpetic Neuralgia Clinical Trial

Official title: Phase II Proof of Concept Trial of Civamide Patch in the Treatment of Post-herpetic Neuralgia and Post-incisional Neuralgia

Status Completed

Clinical Trial Summary

This proof of concept study is designed to evaluate the safety and efficacy of topically administered Civamide Patch for the treatment of moderate to severe daily pain associated with postherpetic neuralgia localized to the trunk, and with localized post-incisional neuropathic pain syndromes on the trunk.

Clinical Trial Description

There will be up to approximately 20 evaluable subjects in this open-label study. The study is composed of a 1-week non-treatment Baseline Period (Day -7 to -1), during which subjects will be required to complete a Daily Diary assessing overall pain and sleep interference. The 1-week Baseline Period will be followed by a 4-week Treatment Period, in which subjects will apply the Civamide Patch (0.015%) daily 12 hours per day, for a period of 4 weeks, complete a Daily Diary assessing overall pain and sleep interference, followed by a 2-week Post-Treatment Observation Period. In the course of the study, subjects will visit the clinic a total of five times for physical examinations, vital signs, review of diaries, and distribution and collection of test patches. Efficacy assessment will be the mean change from Baseline Period in efficacy variables during the course of the study. ;

Related Conditions & MeSH terms

• Neuralgia
• Neuralgia, Postherpetic
• Postherpetic Neuralgia

• NCT number: NCT00845923
• Study type: Interventional
• Source: Winston Laboratories
• Status: Completed
• Phase: Phase 2
• Start date: March 2009
• Completion date: October 2009