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

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ClinicalTrials.gov Identifier: NCT00085761
Recruitment Status : Terminated (Terminated in view of the C107 findings demonstrating efficacy at doses of 90 and 30 minutes)
First Posted : June 17, 2004
Last Update Posted : March 6, 2008
Sponsor:
Information provided by:
NeurogesX

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
HIV Infections Peripheral Nervous System Diseases Pain Drug: Capsaicin Dermal Patch Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Double
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 the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Capsaicin

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00085761


Locations
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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
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ClinicalTrials.gov Identifier: NCT00085761    
Other Study ID Numbers: C112
First Posted: June 17, 2004    Key Record Dates
Last Update Posted: March 6, 2008
Last Verified: March 2008
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:
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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