Pain Clinical Trial
Official title:
A Randomized, Double-Blind, Controlled Dose Finding Study of NGX-4010 for the Treatment of Painful HIV-Associated Distal Symmetrical Polyneuropathy
The purpose of the study is to determine if an investigational drug, NGX-4010 (high-concentration capsaicin patch), is effective in treating painful HIV-associated neuropathy.
The C107 study is a randomized, double-blind, controlled dose finding study of NGX-4010 for
the treatment of painful symptoms of HIV-associated neuropathy. Participants will be
randomly assigned to receive initial treatment according to one of three doses (application
durations), and to receive double-blind NGX-4010 patch (high-concentration capsaicin) or
matching control (low-concentration capsaicin).
Participants who complete study evaluations through Week 12 will have the option of
receiving up to 3 additional open-label treatments.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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