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

NeurogesX

Status and phase: Terminated; Phase 3

Conditions: Peripheral Nervous System Diseases; HIV Infections; Pain

Treatments: Drug: Capsaicin Dermal Patch

Study type: Interventional

Funder types: Industry

Identifiers

NCT00085761

C112

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.