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

Sponsored by:	NeurogesX
Information provided by:	NeurogesX
ClinicalTrials.gov Identifier:	NCT00233155

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 II

MedlinePlus related topics: AIDS Neurologic Diseases Peripheral Nerve Disorders Shingles

Drug Information available for: Capsaicin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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)

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

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

Sponsors and Collaborators

NeurogesX

Investigators

Study Director:

Jeffrey Tobias, MD

NeurogesX

More Information

Study ID Numbers:	C118
Study First Received:	October 3, 2005
Last Updated:	March 4, 2008
ClinicalTrials.gov Identifier:	NCT00233155
Health Authority:	United States: Food and Drug Administration

Keywords provided by NeurogesX:

Analgesics
Capsaicin
Neuropathic pain

Neuropathy
PHN
Shingles

Study placed in the following topic categories:

Herpes Zoster
Neuralgia, Postherpetic
Sexually Transmitted Diseases, Viral
Neuralgia
Acquired Immunodeficiency Syndrome
Pain
Capsaicin
Immunologic Deficiency Syndromes
Herpesviridae Infections

Virus Diseases
Signs and Symptoms
Neuromuscular Diseases
HIV Infections
Peripheral Nervous System Diseases
Sexually Transmitted Diseases
Neurologic Manifestations
DNA Virus Infections
Retroviridae Infections

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Nervous System Diseases
Physiological Effects of Drugs
Infection
Pharmacologic Actions

Sensory System Agents
Therapeutic Uses
Lentivirus Infections
Antipruritics
Peripheral Nervous System Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on January 16, 2009