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

NCT00321672 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 494

Last updated 2011-06-14

Study results available
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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.

Conditions

  • Pain
  • HIV Infections
  • Peripheral Nervous System Diseases

Interventions

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.

Sponsors & Collaborators

  • NeurogesX

    lead INDUSTRY

Principal Investigators

  • Trudy F Vanhove, MD · NeurogesX

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2007-12-31
Completion
2007-12-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00321672 on ClinicalTrials.gov