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

NCT ID: NCT00233155

Last Updated: 2008-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2006-12-31

Brief 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.

Detailed 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.

Conditions

Herpes Zoster; Neuralgia; Pain; HIV Infections; Peripheral Nervous System Diseases

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Capsaicin Dermal Patch

Intervention Type: DRUG

Eligibility Criteria

Exclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NeurogesX

INDUSTRY

Sponsor Role: lead

Principal Investigators

Jeffrey Tobias, MD

Role: STUDY_DIRECTOR

NeurogesX

References

Simpson DM, Gazda S, Brown S, Webster LR, Lu SP, Tobias JK, Vanhove GF; NGX-4010 C118 Study Group. Long-term safety of NGX-4010, a high-concentration capsaicin patch, in patients with peripheral neuropathic pain. J Pain Symptom Manage. 2010 Jun;39(6):1053-64. doi: 10.1016/j.jpainsymman.2009.11.316.

Reference Type: DERIVED

PMID: 20538187 (View on PubMed)

Other Identifiers

C118

Identifier Type: -

Identifier Source: org_study_id