Your Digestive System and How It Works |
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Clinical Trial: Study of NGX-4010 for Treatment of Painful HIV-Associated Neuropathy
This study is currently recruiting patients.
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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 | Treatment or Intervention | Phase |
|---|---|---|
| HIV Infections Peripheral Nervous System Diseases Pain | Drug: Capsaicin Dermal Patch | Phase III |
MedlinePlus related topics: AIDS; Pain; Peripheral Nerve Disorders
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 above, Genders Eligible for Study: Both
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.
Location and Contact Information
Florida
Infectious Disease Associates, Sarasota, Florida, 34239, United States; Recruiting
Virginia
Infectious Diseases Physicians, Annandale, Virginia, 22003, United States; Recruiting
More Information
Record last reviewed: November 2004
Last Updated: November 2, 2004
Record first received: June 14, 2004
ClinicalTrials.gov Identifier: NCT00085761
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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