NCT00321672

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

A Multicenter Randomized, Double-Blind, Controlled Study of NGX-4010 for the Treatment of Painful HIV-Associated Neuropathy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 494 (actual)
• Sponsor: NeurogesX · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study was to assess the efficacy and safety of NGX-4010 applied for 30 or 60 minutes for the treatment of painful HIV-associated neuropathy.

Detailed description

Study C119 was a multicenter, randomized, double-blind, controlled evaluation of the efficacy and safety of NGX-4010 for the treatment of painful HIV-associated neuropathy. Eligible subjects had painful HIV-associated neuropathy resulting from HIV disease and/or antiretroviral drug exposure in both feet, with average numeric pain rating scale (NPRS) scores during screening of 3 to 9 (inclusive). Up to four patches covering an area of up to 1120 square centimeters could be used during a single treatment administration in this study. Subjects were randomly assigned to receive active NGX-4010 patches (8% capsaicin) or low-concentration control patches (0.04% capsaicin) identical in appearance, at doses (patch application duration) of either 30 or 60 minutes, according to a 2:1:2:1 allocation scheme. Subjects could be on stable chronic oral pain medication regimens, but could not be using any topical pain medications on the affected areas. NPRS scores for the average pain in the past 24 hours were recorded daily in the evening, beginning on the day of the Screening Visit (usually on Day -14). Subjects continued to record NPRS scores in a take-home diary from the evening on the day of treatment through the evening before the Termination Visit at Week 12. Subjects returned for interim follow-up visits at Weeks 4 and 8 following study treatment.

Conditions

• Pain
• HIV Infections
• Peripheral Nervous System Diseases

Interventions

Type	Name	Description
DRUG	NGX-4010, 8% capsaicin patch	Up to 4 NGX-4010 patches of 280 cm\^2 each were applied to the feet (2 per foot) for 60 minutes.
DRUG	0.04% capsaicin patch	Up to 4 control patches of 280 cm\^2 each were applied to the feet (2 per foot) for 60 minutes.
DRUG	NGX-4010, 8% capsaicin patch	Up to 4 NGX-4010 patches of 280 cm\^2 each were applied to the feet (2 per foot) for 30 minutes.
DRUG	0.04% capsaicin patch	Up to 4 control patches of 280 cm\^2 each were applied to the feet (2 per foot) for 30 minutes.

Timeline

• Start date: 2006-06-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2006-05-04
• Last updated: 2011-06-14
• Results posted: 2011-06-14