NCT00085761

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 17, 2004

Completed
Last Updated

March 6, 2008

Status Verified

March 1, 2008

First QC Date

June 14, 2004

Last Update Submit

March 4, 2008

Conditions

HIV InfectionsPeripheral Nervous System DiseasesPain

Keywords

Dermal assessmentPain measurementDiaryNeuropathyAnalgesics/*therapeutic useCapsaicin/*administration & dosage/adverse effectsHIV Infections/*complications/*drug therapyPainComplementary Therapies

Interventions

Capsaicin Dermal PatchDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

NeurogesX Investigational Site

Sarasota, Florida, 34239, United States

Location

NeurogesX Investigational Site

Annandale, Virginia, 22003, United States

Location

MeSH Terms

Conditions

HIV InfectionsPeripheral Nervous System DiseasesPain

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesNeuromuscular DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 14, 2004

First Posted

June 17, 2004

Last Updated

March 6, 2008

Record last verified: 2008-03

Locations

US(2)