Study of NGX-4010 for the Treatment of Painful HIV-Associated Neuropathy (HIV-AN) or Postherpetic Neuralgia (PHN)
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
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.
Study Design
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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. []
Eligibility Criteria
Criteria
Summary eligibility criteria:
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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.
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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.
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Topical pain medications are exclusionary and require washout prior to study patch application for this study.
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Chronic, nontopical pain medications are allowed but must be stable (not as needed) for a defined period prior to first study patch application.
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Other specific inclusion and exclusion criteria must be met prior to enrollment on the study.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- NeurogesX
Investigators
- Study Director: Jeffrey Tobias, MD, NeurogesX
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- C118