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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00085761
• Other study ID #: C112
• Status: Terminated
• Phase: Phase 3
• First received: June 14, 2004
• Last updated: March 4, 2008

Study information

• Verified date: March 2008
• Source: NeurogesX
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• HIV Infections
• Nervous System Diseases
• Pain
• Peripheral Nervous System Diseases

Intervention

Drug:
• Capsaicin Dermal Patch

Locations

Country	Name	City	State
United States	NeurogesX Investigational Site	Annandale	Virginia
United States	NeurogesX Investigational Site	Sarasota	Florida

Sponsors (1)

Lead Sponsor	Collaborator
NeurogesX

Country where clinical trial is conducted

United States,