Study of NGX-4010 for the Treatment of Painful HIV-Associated Neuropathy (HIV-AN) or Postherpetic Neuralgia (PHN)
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.
Peripheral Nervous System Diseases
Drug: Capsaicin Dermal Patch
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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)|
- 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).
- 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.
- Proportion of subjects with significant changes in concomitant pain medication usage during the 2nd through 12th week following study patch application.
|Study Start Date:||August 2005|
|Estimated Study Completion Date:||December 2006|
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.