CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 494 enrolled
Drug / intervention
NGX-4010, 8% capsaicin patch +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00321672
NCT00321672Phase 3Completed
CompareCT.gov

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

NeurogesX·interventional·Posted May 4, 2006·Updated Jun 14, 2011

In Brief

A Phase 3 clinical trial evaluating NGX-4010, 8% capsaicin patch and 0.04% capsaicin patch for Pain and 2 related conditions. Completed, enrolled 494 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, HIV Infections, Peripheral Nervous System Diseases
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 4, 2006
Enrollment StartJun 1, 2006
Primary CompletionDec 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 20.2 years ago

Interventions

NGX-4010, 8% capsaicin patchdrug

Up to 4 NGX-4010 patches of 280 cm\^2 each were applied to the feet (2 per foot) for 60 minutes.

0.04% capsaicin patchdrug

Up to 4 control patches of 280 cm\^2 each were applied to the feet (2 per foot) for 60 minutes.

NGX-4010, 8% capsaicin patchdrug

Up to 4 NGX-4010 patches of 280 cm\^2 each were applied to the feet (2 per foot) for 30 minutes.

0.04% capsaicin patchdrug

Up to 4 control patches of 280 cm\^2 each were applied to the feet (2 per foot) for 30 minutes.