The purpose of this study is to assess the efficacy, safety and tolerability of NGX-1998 applied for 5 minutes for the treatment of postherpetic neuralgia (PHN).
This study is a 12-week multicenter randomized, double-blind, controlled evaluation of the efficacy, safety and tolerability of NGX-1998 for the treatment of postherpetic neuralgia (PHN). Eligible subjects will have pain from PHN, with average numeric pain rating scale (NPRS) scores during screening of 4 to 9 (inclusive). Painful areas of up to 1500 cm2 will be treated during a single Test Article application. Subjects will be randomly assigned to receive NGX-1998 (10% or 20% w/w) or placebo according to an unequal allocation scheme of 2:2:1. Subjects will also be stratified by gender.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
183
Capsaicin topical liquid to be applied for 5 minutes one time only.
Placebo topical liquid to be applied for 5 minutes one time only.
Percent change from baseline in the "average pain for the past 24 hours" NPRS score during Weeks 2-8.
Time frame: Weeks 2-8
Absolute change and percent change from baseline in the "average pain for the past 24 hours" NPRS score at Week 8 and 12
Time frame: Week 8 and Week 12
Absolute change and percent change from baseline in the "average pain for the past 24 hours" NPRS score during Weeks 2-12.
Time frame: Weeks 2-12
Proportion of subjects with at least a 30% decrease from baseline in their "average pain for the past 24 hours" NPRS during Weeks 2-8, Weeks 2-12, at Week 8 and Week 12.
Time frame: Weeks 2-12
Proportion of subjects with at least a 2 unit decrease from baseline in their "average pain for the past 24 hours" NPRS during Weeks 2-8, Weeks 2-12, at Week 8 and Week 12.
Time frame: Week 8 and Week 12
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