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

Pain Clinical Trial

Official title:

A Multicenter, Open-Label, Phase 2 Study of NGX-4010 for the Treatment of Neuropathic Pain in Patients With Painful HIV-Associated Neuropathy (HIV-AN) or Postherpetic Neuralgia (PHN)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00233155
• Other study ID #: C118
• Status: Completed
• Phase: Phase 2
• First received: October 3, 2005
• Last updated: March 4, 2008
• Start date: August 2005
• Est. completion date: December 2006

Study information

• Verified date: March 2008
• Source: NeurogesX
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Herpes Zoster
• HIV Infections
• Nervous System Diseases
• Neuralgia
• Neuralgia, Postherpetic
• Pain
• Peripheral Nervous System Diseases

Intervention

Drug:
• Capsaicin Dermal Patch

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
NeurogesX

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean percent change from baseline in "average pain for the past 24 hours" NPRS score (i.e., average of scores during Weeks 12 and 48, compared to baseline).
Secondary	Proportion of subjects who score 2 or 3 ("Much Improved" or "Very Much Improved") on Patient Impression of Change at Weeks 12, 24, 36 and 48.
Secondary	Proportion of subjects with significant changes in concomitant pain medication usage during the 2nd through 12th week following study patch application.