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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:
ClinicalTrials.gov Identifier:
NCT00085761
First Posted: June 17, 2004
Last Update Posted: March 6, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NeurogesX
June 14, 2004
June 17, 2004
March 6, 2008
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Complete list of historical versions of study NCT00085761 on ClinicalTrials.gov Archive Site
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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.
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Interventional
Phase 3
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
  • HIV Infections
  • Peripheral Nervous System Diseases
  • Pain
Drug: Capsaicin Dermal Patch
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
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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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00085761
C112
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NeurogesX
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NeurogesX
March 2008

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