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

June 14, 2004
March 4, 2008
Not Provided
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00085761 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of NGX-4010 for Treatment of Painful HIV-Associated Neuropathy
An International, Multicenter, Randomized, Double-Blind, 12-Week Controlled Study of NGX-4010 for Treatment of Painful HIV-Associated Neuropathy

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Double-Blind
Primary Purpose: Treatment
  • HIV Infections
  • Peripheral Nervous System Diseases
  • Pain
Drug: Capsaicin Dermal Patch
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
Not Provided
Not Provided
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00085761
C112
Not Provided
Not Provided
NeurogesX
Not Provided
Not Provided
NeurogesX
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP