Study of NGX-4010 for Treatment of Painful HIV-Associated Neuropathy

This study has been terminated.

(Terminated in view of the C107 findings demonstrating efficacy at doses of 90 and 30 minutes)

Sponsor:

Information provided by:

NeurogesX

ClinicalTrials.gov Identifier:

NCT00085761

First received: June 14, 2004

Last updated: March 4, 2008

Last verified: March 2008

History of Changes

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 3


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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Neurologic Diseases

Drug Information available for: Capsaicin

U.S. FDA Resources

Further study details as provided by NeurogesX:

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

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: 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


ClinicalTrials.gov Identifier:	NCT00085761 History of Changes
Other Study ID Numbers:	C112
Study First Received:	June 14, 2004
Last Updated:	March 4, 2008
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

Additional relevant MeSH terms:


HIV Infections Nervous System Diseases 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 Neuromuscular Diseases Capsaicin Antipruritics Dermatologic Agents Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 26, 2016

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