Study of NGX-4010 for the Treatment of Painful HIV-Associated Neuropathy (HIV-AN) or Postherpetic Neuralgia (PHN)
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ClinicalTrials.gov Identifier: NCT00233155 |
Recruitment Status
:
Completed
First Posted
: October 5, 2005
Last Update Posted
: March 6, 2008
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Herpes Zoster Neuralgia Pain HIV Infections Peripheral Nervous System Diseases | Drug: Capsaicin Dermal Patch | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 100 participants |
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) |
Study Start Date : | August 2005 |
Study Completion Date : | December 2006 |

- 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.

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00233155
Study Director: | Jeffrey Tobias, MD | NeurogesX |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00233155 History of Changes |
Other Study ID Numbers: |
C118 |
First Posted: | October 5, 2005 Key Record Dates |
Last Update Posted: | March 6, 2008 |
Last Verified: | March 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 |