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Study of NGX-4010 for the Treatment of Painful HIV-Associated Neuropathy (HIV-AN) or Postherpetic Neuralgia (PHN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00233155
Recruitment Status : Completed
First Posted : October 5, 2005
Last Update Posted : March 6, 2008
Information provided by:

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
Herpes Zoster Neuralgia Pain HIV Infections Peripheral Nervous System Diseases Drug: Capsaicin Dermal Patch 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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Shingles
Drug Information available for: Capsaicin

Primary Outcome Measures :
  1. 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 :
  1. 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.
  2. Proportion of subjects with significant changes in concomitant pain medication usage during the 2nd through 12th week following study patch application.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00233155

Sponsors and Collaborators
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Study Director: Jeffrey Tobias, MD NeurogesX
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00233155    
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:
Neuropathic pain
Additional relevant MeSH terms:
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Herpes Zoster
Neuralgia, Postherpetic
Peripheral Nervous System Diseases
Nervous System Diseases
Virus Diseases
Neuromuscular Diseases
Neurologic Manifestations
Signs and Symptoms
Varicella Zoster Virus Infection
Herpesviridae Infections
DNA Virus Infections
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs