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.

ClinicalTrials.gov Identifier: NCT00233155

Recruitment Status : Completed

First Posted : October 5, 2005

Last Update Posted : March 6, 2008

Sponsor:

Information provided by:

NeurogesX

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
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.

Study Design


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

Genetics Home Reference related topics: Shingles

MedlinePlus related topics: HIV/AIDS Shingles

Drug Information available for: Capsaicin

U.S. FDA Resources

Arms and Interventions

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

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.


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

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 ClinicalTrials.gov identifier (NCT number): 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):

Simpson DM, Gazda S, Brown S, Webster LR, Lu SP, Tobias JK, Vanhove GF; NGX-4010 C118 Study Group. Long-term safety of NGX-4010, a high-concentration capsaicin patch, in patients with peripheral neuropathic pain. J Pain Symptom Manage. 2010 Jun;39(6):1053-64. doi: 10.1016/j.jpainsymman.2009.11.316.


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

To Top