Study of NGX-4010 for the Treatment of Painful HIV-Associated Neuropathy (HIV-AN) or Postherpetic Neuralgia (PHN)
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Herpes Zoster Neuralgia Pain HIV Infections Peripheral Nervous System Diseases |
Drug: Capsaicin Dermal Patch |
Phase 2 |
| Study Type: | Interventional |
| 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.
| Estimated Enrollment: | 100 |
| 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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
No publications provided by NeurogesX
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00233155 History of Changes |
| Other Study ID Numbers: | C118 |
| Study First Received: | October 3, 2005 |
| Last Updated: | March 4, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by NeurogesX:
|
Analgesics Capsaicin Neuropathic pain |
Neuropathy PHN Shingles |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Herpes Zoster Nervous System Diseases Neuralgia Peripheral Nervous System Diseases Neuralgia, Postherpetic Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Slow Virus Diseases Herpesviridae Infections DNA Virus Infections Pain Neurologic Manifestations Neuromuscular Diseases Signs and Symptoms Capsaicin Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Antipruritics Dermatologic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013