NCT00064623

Study of NGX-4010 for the Treatment of Painful HIV-Associated Neuropathy

A Randomized, Double-Blind, Controlled Dose Finding Study of NGX-4010 for the Treatment of Painful HIV-Associated Distal Symmetrical Polyneuropathy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (planned)
• Sponsor: NeurogesX · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• HIV Infections
• Peripheral Nervous System Diseases
• Pain

Interventions

Type	Name	Description
DRUG	Capsaicin Dermal Patch

Timeline

• Start date: 2003-08-01
• Completion: 2005-11-01
• First posted: 2003-07-11
• Last updated: 2008-03-06

Locations

35 sites across 1 country: United States