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NGX-4010 for the Treatment of Postherpetic Neuralgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00061776
Recruitment Status : Completed
First Posted : June 4, 2003
Last Update Posted : March 6, 2008
Sponsor:
Information provided by:
NeurogesX

Brief 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).

Condition or disease Intervention/treatment Phase
Herpes Zoster Neuralgia Pain Peripheral Nervous System Diseases Shingles Drug: Capsaicin Dermal Patch Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Controlled Dose Finding Study of NGX-4010 for the Treatment of Postherpetic Neuralgia

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Shingles
MedlinePlus related topics: Shingles
Drug Information available for: Capsaicin





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00061776


Locations
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United States, Alabama
NeurogesX Investigational Site
Huntsville, Alabama, United States, 35801
United States, Arizona
NeurogesX Investigational Site
Phoenix, Arizona, United States, 85023
NeurogesX Investigational Site
Scottsdale, Arizona, United States
NeurogesX Investigational Site
Tucson, Arizona, United States, 85724
United States, Arkansas
NeurogesX Investigational Site
Little Rock, Arkansas, United States, 72205
United States, California
NeurogesX Investigational Site
La Jolla, California, United States, 92037
NeurogesX Investigational Site
San Francisco, California, United States, 94117
United States, Colorado
NeurogesX Investigational Site
Denver, Colorado, United States, 80218
United States, Florida
NeurogesX Investigational Site
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
United States, Massachusetts
NeurogesX Investigational Site
Boston, Massachusetts, United States, 02115
United States, Missouri
NeurogesX Investigational Site
Kansas City, Missouri, United States, 64132
United States, Nevada
NeurogesX Investigational Site
Las Vegas, Nevada, United States, 89102
United States, New Jersey
NeurogesX Investigational Site
Morristown, New Jersey, United States, 07960
United States, New York
NeurogesX Investigational Site
Albany, New York, United States, 12205
NeurogesX Investigational Site
Rochester, New York, United States, 14642
United States, Oregon
NeurogesX Investigational Site
Eugene, Oregon, United States, 97401
United States, Tennessee
NeurogesX Investigational Site
Memphis, Tennessee, United States, 93104
United States, Texas
NeurogesX Investigational Site
Austin, Texas, United States, 78758
NeurogesX Investigational Site
Dallas, Texas, United States, 75234
NeurogesX Investigational Site
San Antonio, Texas, United States, 78229
United States, Utah
NeurogesX Investigational Site
Salt Lake City, Utah, United States, 84107
United States, Washington
NeurogesX Investigational Site
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
NeurogesX
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ClinicalTrials.gov Identifier: NCT00061776    
Other Study ID Numbers: C108
First Posted: June 4, 2003    Key Record Dates
Last Update Posted: March 6, 2008
Last Verified: March 2008
Keywords provided by NeurogesX:
Dermal assessment
Pain measurement
Diary
Shingles
Neuropathy
Analgesics/*therapeutic use
Capsaicin/*administration & dosage/adverse effects
Herpes Zoster/*complications/drug therapy
Neuralgia/*drug therapy/etiology
Pain
Peripheral Nervous System Diseases/*complications
Additional relevant MeSH terms:
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Herpes Zoster
Neuralgia
Nervous System Diseases
Neuralgia, Postherpetic
Peripheral Nervous System Diseases
Neuromuscular Diseases
Pain
Neurologic Manifestations
Varicella Zoster Virus Infection
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Infections
Capsaicin
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs