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

NeurogesX

Status and phase

Completed

Phase 2

Conditions

Peripheral Nervous System Diseases

HIV Infections

Herpes Zoster

Pain

Neuralgia

Treatments

Drug: Capsaicin Dermal Patch

Study type

Interventional

Funder types

Industry

Identifiers

NCT00233155

C118

Details and patient eligibility

About

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.

Full description

Study C118 is a multicenter, open-label, single-arm study for subjects who successfully completed a previous NGX-4010 study and have not received open-label or blinded NGX-4010 study patches within the 12 weeks prior to study entry. One hundred eligible subjects will receive an initial open-label NGX-4010 study patch application and up to three additional open-label NGX-4010 applications at intervals of no less than 12 weeks, based on the presence or return of pain. Eligible subjects will have moderate to severe neuropathic pain secondary to HIV-AN or PHN, with average pain levels deemed appropriate for further treatment with NGX-4010 as judged by the Investigator.

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.