NGX-4010 for the Treatment of Postherpetic Neuralgia

NCT ID: NCT00061776

Last Updated: 2008-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Herpes Zoster Neuralgia Pain Peripheral Nervous System Diseases Shingles

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Capsaicin Dermal Patch

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NeurogesX

INDUSTRY

Sponsor Role lead

Locations

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NeurogesX Investigational Site

Huntsville, Alabama, United States

Site Status

NeurogesX Investigational Site

Phoenix, Arizona, United States

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NeurogesX Investigational Site

Scottsdale, Arizona, United States

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NeurogesX Investigational Site

Tucson, Arizona, United States

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NeurogesX Investigational Site

Little Rock, Arkansas, United States

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NeurogesX Investigational Site

La Jolla, California, United States

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NeurogesX Investigational Site

San Francisco, California, United States

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NeurogesX Investigational Site

Denver, Colorado, United States

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NeurogesX Investigational Site

Melbourne, Florida, United States

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NeurogesX Investigational Site

Naples, Florida, United States

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NeurogesX Investigational Site

Ocala, Florida, United States

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NeurogesX Investigational Site

Palm Beach Garden, Florida, United States

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NeurogesX Investigational Site

Plantation, Florida, United States

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NeurogesX Investigational Site

Sarasota, Florida, United States

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NeurogesX Investigational Site

St. Petersburg, Florida, United States

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NeurogesX Investigational Site

Boston, Massachusetts, United States

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NeurogesX Investigational Site

Kansas City, Missouri, United States

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NeurogesX Investigational Site

Las Vegas, Nevada, United States

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NeurogesX Investigational Site

Morristown, New Jersey, United States

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Albany, New York, United States

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NeurogesX Investigational Site

Rochester, New York, United States

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NeurogesX Investigational Site

Eugene, Oregon, United States

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NeurogesX Investigational Site

Memphis, Tennessee, United States

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Austin, Texas, United States

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NeurogesX Investigational Site

Dallas, Texas, United States

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NeurogesX Investigational Site

San Antonio, Texas, United States

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NeurogesX Investigational Site

Salt Lake City, Utah, United States

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NeurogesX Investigational Site

Tacoma, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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C108

Identifier Type: -

Identifier Source: org_study_id

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