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

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)

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Neurologic Diseases Peripheral Nerve Disorders Shingles

Drug Information available for: Capsaicin

U.S. FDA Resources

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

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.

Eligibility


Genders Eligible for Study:	Both
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

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00233155

Sponsors and Collaborators

NeurogesX

Investigators


Study Director:	Jeffrey Tobias, MD	NeurogesX

More Information

No publications provided by NeurogesX

Additional 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
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:


Acquired Immunodeficiency Syndrome HIV Infections Herpes Zoster Nervous System Diseases Neuralgia Neuralgia, Postherpetic Peripheral Nervous System Diseases DNA Virus Infections Herpesviridae Infections Immune System Diseases Immunologic Deficiency Syndromes Lentivirus Infections Neurologic Manifestations Neuromuscular Diseases Pain	RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Signs and Symptoms Slow Virus Diseases Virus Diseases Capsaicin Antipruritics Dermatologic Agents Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Sensory System Agents Therapeutic Uses

ClinicalTrials.gov processed this record on February 25, 2015