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Study of NGX-4010 for the Treatment of Painful HIV-Associated Neuropathy (HIV-AN) or Postherpetic Neuralgia (PHN)
This study has been completed.
Sponsor:
NeurogesX
Information provided by:
NeurogesX
ClinicalTrials.gov Identifier:
NCT00233155
First received: October 3, 2005
Last updated: March 4, 2008
Last verified: March 2008
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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 Intervention Model: Single Group Assignment Masking: None (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) |
Resource links provided by NLM:
Further study details as provided by NeurogesX:
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.
| 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| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00233155
Please refer to this study by its ClinicalTrials.gov identifier: NCT00233155
Sponsors and Collaborators
NeurogesX
Investigators
| Study Director: | Jeffrey Tobias, MD | NeurogesX |
More Information
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 |
Keywords provided by NeurogesX:
|
Analgesics Capsaicin Neuropathic pain |
Neuropathy PHN Shingles |
Additional relevant MeSH terms:
|
HIV Infections Neuralgia Nervous System Diseases Herpes Zoster Neuralgia, Postherpetic Peripheral Nervous System Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes |
Immune System Diseases Pain Neurologic Manifestations Neuromuscular Diseases Signs and Symptoms Herpesviridae Infections DNA Virus Infections Capsaicin Antipruritics Dermatologic Agents Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 21, 2017