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

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Primary Purpose

Status

Terminated

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Capsaicin Dermal Patch

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Dermal assessment, Pain measurement, Diary, Neuropathy, Analgesics/*therapeutic use, Capsaicin/*administration & dosage/adverse effects, HIV Infections/*complications/*drug therapy, Pain, Complementary Therapies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

NeurogesX Investigational Site
NeurogesX Investigational Site

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00085761

First Posted

June 14, 2004

Last Updated

March 4, 2008

Sponsor

NeurogesX

1. Study Identification

Unique Protocol Identification Number

NCT00085761

Brief Title

Study of NGX-4010 for Treatment of 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 Type

Interventional

2. Study Status

Record Verification Date

March 2008

Overall Recruitment Status

Terminated

Why Stopped

Terminated in view of the C107 findings demonstrating efficacy at doses of 90 and 30 minutes

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

NeurogesX

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections, Peripheral Nervous System Diseases, Pain

Keywords

Dermal assessment, Pain measurement, Diary, Neuropathy, Analgesics/*therapeutic use, Capsaicin/*administration & dosage/adverse effects, HIV Infections/*complications/*drug therapy, Pain, Complementary Therapies

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Masking

Double

Allocation

Randomized

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Capsaicin Dermal Patch

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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.

Facility Information:

Facility Name

NeurogesX Investigational Site

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34239

Country

United States

Facility Name

NeurogesX Investigational Site

City

Annandale

State/Province

Virginia

ZIP/Postal Code

22003

Country

United States

HIV Infections, Peripheral Nervous System Diseases, Pain

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial