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NCT00061776 Clinical Trial

NGX-4010 for the Treatment of Postherpetic Neuralgia

Pain Clinical Trial

Official title:
A Randomized, Double-Blind, Controlled Dose Finding Study of NGX-4010 for the Treatment of Postherpetic Neuralgia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00061776
Other study ID # C108
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received June 3, 2003
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 determine if an investigational drug, NGX-4010 (high-concentration capsaicin dermal patches) is effective in treating pain associated with post-herpetic neuralgia (PHN).

Description:

Participants will be randomly assigned to receive initial treatment according to one of three doses (application durations), and will receive either NGX-4010 patch (high-concentration capsaicin) or matching control (low-concentration capsaicin).

Participants who complete the study evaluations for 12 weeks will have the option of receiving up to 3 additional open-label re-treatments over 1 year.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Key Eligibility Criteria:

- Must be diagnosed with PHN and be at least 6 months after crusting of the skin vesicles, with moderate to severe pain.

- Must not have significant pain due to causes other than PHN (for example, arthritis).

- Painful areas should not be located on the face, above the hairline of the scalp, and/or in proximity to mucous membranes.

- Must have intact and unbroken 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 (1-year).

- Must not have any implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator) for the treatment of pain.

- Must not use topical pain medications for PHN.

- Must be able to comply with study requirements such as completing a daily pain diary, attending study visits and refraining from extensive travel during study participation.

- 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

Intervention

Drug:
• Capsaicin Dermal Patch

Locations
Country Name City State
United States NeurogesX Investigational Site Albany New York
United States NeurogesX Investigational Site Austin Texas
United States NeurogesX Investigational Site Boston Massachusetts
United States NeurogesX Investigational Site Dallas Texas
United States NeurogesX Investigational Site Denver Colorado
United States NeurogesX Investigational Site Eugene Oregon
United States NeurogesX Investigational Site Huntsville Alabama
United States NeurogesX Investigational Site Kansas City Missouri
United States NeurogesX Investigational Site La Jolla California
United States NeurogesX Investigational Site Las Vegas Nevada
United States NeurogesX Investigational Site Little Rock Arkansas
United States NeurogesX Investigational Site Melbourne Florida
United States NeurogesX Investigational Site Memphis Tennessee
United States NeurogesX Investigational Site Morristown New Jersey
United States NeurogesX Investigational Site Naples Florida
United States NeurogesX Investigational Site Ocala Florida
United States NeurogesX Investigational Site Palm Beach Garden Florida
United States NeurogesX Investigational Site Phoenix Arizona
United States NeurogesX Investigational Site Plantation Florida
United States NeurogesX Investigational Site Rochester New York
United States NeurogesX Investigational Site Salt Lake City Utah
United States NeurogesX Investigational Site San Antonio Texas
United States NeurogesX Investigational Site San Francisco California
United States NeurogesX Investigational Site Sarasota Florida
United States NeurogesX Investigational Site Scottsdale Arizona
United States NeurogesX Investigational Site St. Petersburg Florida
United States NeurogesX Investigational Site Tacoma Washington
United States NeurogesX Investigational Site Tucson Arizona

Sponsors (1)
Lead Sponsor Collaborator
NeurogesX

Country where clinical trial is conducted

United States, 

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