Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  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:


Further study details as provided by NeurogesX:

  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
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

No publications provided

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:
Acquired Immunodeficiency Syndrome
HIV Infections
Infection
Nervous System Diseases
Peripheral Nervous System Diseases
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Neuromuscular Diseases
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
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 November 27, 2014