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

Condition(s) targeted: HIV Infections; Peripheral Nervous System Diseases; Pain

Intervention: Capsaicin Dermal Patch (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: NeurogesX

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.

Official title: An International, Multicenter, Randomized, Double-Blind, 12-Week Controlled Study of NGX-4010 for Treatment of Painful HIV-Associated Neuropathy

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment

Minimum age: 18 Years. Maximum age: N/A. Gender(s): 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.

NeurogesX Investigational Site, Sarasota, Florida 34239, United States

NeurogesX Investigational Site, Annandale, Virginia 22003, United States

Last updated: March 4, 2008