Study of NGX-4010 for Treatment of Painful HIV-Associated Neuropathy - Full Text View

Sponsored by:	NeurogesX
Information provided by:	NeurogesX
ClinicalTrials.gov Identifier:	NCT00085761

Purpose

The purpose of the study is to determine if an investigational drug, NGX-4010 (high-concentration capsaicin patch), is safe, tolerable and effective in treating painful HIV-associated neuropathy.

Condition	Intervention	Phase
HIV Infections Peripheral Nervous System Diseases Pain	Drug: Capsaicin Dermal Patch	Phase III

MedlinePlus related topics: AIDS Neurologic Diseases Peripheral Nerve Disorders

Drug Information available for: Capsaicin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Safety/Efficacy Study
Official Title:	An International, Multicenter, Randomized, Double-Blind, 12-Week Controlled Study of NGX-4010 for Treatment of Painful HIV-Associated Neuropathy

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Key Eligibility Criteria:

Must have had HIV-associated neuropathy for at least 2 months, with moderate to severe pain in both feet.
Must not have significant pain in feet due to other causes (for example, arthritis).
Must have intact skin at the treatment area.
Must be prepared to remain on the same pain medications at the same doses as before the study for the entire duration of the study (12 weeks).
Must not use topical pain medications for HIV-associated neuropathy.
Must be able to comply with study requirements such as completing daily pain diary and attending study visits.
Must be at least 18 years old, not pregnant, and be able to take care of self independently, with only occasional assistance if needed.
No significant medical problems of the heart, kidneys, liver or lungs, or cancer.
No history or current problem with substance abuse.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00085761

Locations

United States, Florida
NeurogesX Investigational Site
Sarasota, Florida, United States, 34239
United States, Virginia
NeurogesX Investigational Site
Annandale, Virginia, United States, 22003

Sponsors and Collaborators

NeurogesX

More Information

Study ID Numbers:	C112
Study First Received:	June 14, 2004
Last Updated:	March 4, 2008
ClinicalTrials.gov Identifier:	NCT00085761
Health Authority:	United States: Food and Drug Administration

Keywords provided by NeurogesX:

Dermal assessment
Pain measurement
Diary
Neuropathy
Analgesics/*therapeutic use

Capsaicin/*administration & dosage/adverse effects
HIV Infections/*complications/*drug therapy
Pain
Complementary Therapies

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
Neuromuscular Diseases
HIV Infections
Peripheral Nervous System Diseases
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Pain
Capsaicin
Retroviridae Infections
Immunologic Deficiency Syndromes

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