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NGX-4010 for the Treatment of Postherpetic Neuralgia

This study has been completed.

Sponsored by: NeurogesX
Information provided by: NeurogesX
ClinicalTrials.gov Identifier: NCT00061776
  Purpose

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 Intervention Phase
Herpes Zoster
Neuralgia
Pain
Peripheral Nervous System Diseases
Shingles
Drug: Capsaicin Dermal Patch
Phase II
Phase III

MedlinePlus related topics:   Neurologic Diseases    Peripheral Nerve Disorders    Shingles   

ChemIDplus related topics:   Capsaicin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Dose Comparison, Safety/Efficacy Study
Official Title:   A Randomized, Double-Blind, Controlled Dose Finding Study of NGX-4010 for the Treatment of Postherpetic Neuralgia

Further study details as provided by NeurogesX:

Estimated Enrollment:   300

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
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00061776

Show 28 study locations  Show 28 Study Locations

Sponsors and Collaborators
NeurogesX
  More Information

Study ID Numbers:   C108
First Received:   June 3, 2003
Last Updated:   March 4, 2008
ClinicalTrials.gov Identifier:   NCT00061776
Health Authority:   United States: Food and Drug Administration

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

Study placed in the following topic categories:
Virus Diseases
Neuralgia, Postherpetic
Herpes Zoster
Signs and Symptoms
Neuromuscular Diseases
Neuralgia
Peripheral Nervous System Diseases
Neurologic Manifestations
DNA Virus Infections
Pain
Capsaicin
Herpesviridae Infections

Additional relevant MeSH terms:
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Antipruritics
Peripheral Nervous System Agents
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2008




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