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NGX-4010 for the Treatment of Postherpetic Neuralgia

Information source: NeurogesX
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Herpes Zoster; Neuralgia; Pain; Peripheral Nervous System Diseases; Shingles

Intervention: Capsaicin Dermal Patch (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: NeurogesX

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).

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double-Blind, Primary Purpose: 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

NeurogesX Investigational Site, Huntsville, Alabama 35801, United States

NeurogesX Investigational Site, Phoenix, Arizona 85023, United States

NeurogesX Investigational Site, Scottsdale, Arizona, United States

NeurogesX Investigational Site, Tucson, Arizona 85724, United States

NeurogesX Investigational Site, Little Rock, Arkansas 72205, United States

NeurogesX Investigational Site, La Jolla, California 92037, United States

NeurogesX Investigational Site, San Francisco, California 94117, United States

NeurogesX Investigational Site, Denver, Colorado 80218, United States

NeurogesX Investigational Site, Melbourne, Florida 32935, United States

NeurogesX Investigational Site, Naples, Florida 34102, United States

NeurogesX Investigational Site, Ocala, Florida 34471, United States

NeurogesX Investigational Site, Palm Beach Garden, Florida 33410, United States

NeurogesX Investigational Site, Plantation, Florida 33324, United States

NeurogesX Investigational Site, Sarasota, Florida 34232, United States

NeurogesX Investigational Site, St. Petersburg, Florida 33702, United States

NeurogesX Investigational Site, Boston, Massachusetts 02115, United States

NeurogesX Investigational Site, Kansas City, Missouri 64132, United States

NeurogesX Investigational Site, Las Vegas, Nevada 89102, United States

NeurogesX Investigational Site, Morristown, New Jersey 07960, United States

NeurogesX Investigational Site, Albany, New York 12205, United States

NeurogesX Investigational Site, Rochester, New York 14642, United States

NeurogesX Investigational Site, Eugene, Oregon 97401, United States

NeurogesX Investigational Site, Memphis, Tennessee 93104, United States

NeurogesX Investigational Site, Austin, Texas 78758, United States

NeurogesX Investigational Site, Dallas, Texas 75234, United States

NeurogesX Investigational Site, San Antonio, Texas 78229, United States

NeurogesX Investigational Site, Salt Lake City, Utah 84107, United States

NeurogesX Investigational Site, Tacoma, Washington 98405, United States

Additional Information


Last updated: March 4, 2008

Page last updated: August 20, 2015

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