Study of NGX-4010 for the Treatment of Painful HIV-Associated Neuropathy (HIV-AN) or Postherpetic Neuralgia (PHN)

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate the safety and efficacy of NGX-4010 administered at intervals of no less than 12 weeks over 1 year, based on the presence or return of pain, for the treatment of painful HIV-AN and PHN. Participation is limited to former study subjects from previous trials of NGX-4010 at selected sites.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NeurogesX
• Treatments: Capsaicin

Criteria

Summary eligibility criteria:

• Subjects must be in good health and have successfully completed a past trial of NGX-4010 with no past occurrence of adverse events that would contraindicate further treatment.

• The time between the last study patch on the previous study and the first study patch on this study must be at least 12 weeks.

• Topical pain medications are exclusionary and require washout prior to study patch application for this study.

• Chronic, nontopical pain medications are allowed but must be stable (not as needed) for a defined period prior to first study patch application.

• Other specific inclusion and exclusion criteria must be met prior to enrollment on the study.