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

Status:

TERMINATED

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

Lead Sponsor:

NeurogesX

Conditions:

HIV Infections

Peripheral Nervous System Diseases

Eligibility:

All Genders

18+ years

Phase:

PHASE3

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.

Eligibility Criteria

Inclusion

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.

Exclusion

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00085761

Last Update

March 6 2008

Active Locations (2)

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Page 1 of 1 (2 locations)

NeurogesX Investigational Site

Sarasota, Florida, United States, 34239