NGX-4010 for the Treatment of Postherpetic Neuralgia

March 4, 2008 updated by: NeurogesX

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment

300

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • NeurogesX Investigational Site
    • Arizona
      • Phoenix, Arizona, United States, 85023
        • NeurogesX Investigational Site
      • Scottsdale, Arizona, United States
        • NeurogesX Investigational Site
      • Tucson, Arizona, United States, 85724
        • NeurogesX Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • NeurogesX Investigational Site
    • California
      • La Jolla, California, United States, 92037
        • NeurogesX Investigational Site
      • San Francisco, California, United States, 94117
        • NeurogesX Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80218
        • NeurogesX Investigational Site
    • Florida
      • Melbourne, Florida, United States, 32935
        • NeurogesX Investigational Site
      • Naples, Florida, United States, 34102
        • NeurogesX Investigational Site
      • Ocala, Florida, United States, 34471
        • NeurogesX Investigational Site
      • Palm Beach Garden, Florida, United States, 33410
        • NeurogesX Investigational Site
      • Plantation, Florida, United States, 33324
        • NeurogesX Investigational Site
      • Sarasota, Florida, United States, 34232
        • NeurogesX Investigational Site
      • St. Petersburg, Florida, United States, 33702
        • NeurogesX Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • NeurogesX Investigational Site
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • NeurogesX Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • NeurogesX Investigational Site
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • NeurogesX Investigational Site
    • New York
      • Albany, New York, United States, 12205
        • NeurogesX Investigational Site
      • Rochester, New York, United States, 14642
        • NeurogesX Investigational Site
    • Oregon
      • Eugene, Oregon, United States, 97401
        • NeurogesX Investigational Site
    • Tennessee
      • Memphis, Tennessee, United States, 93104
        • NeurogesX Investigational Site
    • Texas
      • Austin, Texas, United States, 78758
        • NeurogesX Investigational Site
      • Dallas, Texas, United States, 75234
        • NeurogesX Investigational Site
      • San Antonio, Texas, United States, 78229
        • NeurogesX Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • NeurogesX Investigational Site
    • Washington
      • Tacoma, Washington, United States, 98405
        • NeurogesX Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NeurogesX

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

June 3, 2003

First Submitted That Met QC Criteria

June 3, 2003

First Posted (Estimate)

June 4, 2003

Study Record Updates

Last Update Posted (Estimate)

March 6, 2008

Last Update Submitted That Met QC Criteria

March 4, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C108

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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