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NGX-4010 for the Treatment of Postherpetic Neuralgia

Sponsor
NeurogesX (Industry)
Overall Status
Completed
CT.gov ID
NCT00061776
Collaborator
(none)
300
Enrollment
28
Locations
10.7
Patients Per Site

Study Details

Study Description

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
  • 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.

Study Design

Study Type:
Interventional
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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 NeurogesX Investigational Site Huntsville Alabama United States 35801
    2 NeurogesX Investigational Site Phoenix Arizona United States 85023
    3 NeurogesX Investigational Site Scottsdale Arizona United States
    4 NeurogesX Investigational Site Tucson Arizona United States 85724
    5 NeurogesX Investigational Site Little Rock Arkansas United States 72205
    6 NeurogesX Investigational Site La Jolla California United States 92037
    7 NeurogesX Investigational Site San Francisco California United States 94117
    8 NeurogesX Investigational Site Denver Colorado United States 80218
    9 NeurogesX Investigational Site Melbourne Florida United States 32935
    10 NeurogesX Investigational Site Naples Florida United States 34102
    11 NeurogesX Investigational Site Ocala Florida United States 34471
    12 NeurogesX Investigational Site Palm Beach Garden Florida United States 33410
    13 NeurogesX Investigational Site Plantation Florida United States 33324
    14 NeurogesX Investigational Site Sarasota Florida United States 34232
    15 NeurogesX Investigational Site St. Petersburg Florida United States 33702
    16 NeurogesX Investigational Site Boston Massachusetts United States 02115
    17 NeurogesX Investigational Site Kansas City Missouri United States 64132
    18 NeurogesX Investigational Site Las Vegas Nevada United States 89102
    19 NeurogesX Investigational Site Morristown New Jersey United States 07960
    20 NeurogesX Investigational Site Albany New York United States 12205
    21 NeurogesX Investigational Site Rochester New York United States 14642
    22 NeurogesX Investigational Site Eugene Oregon United States 97401
    23 NeurogesX Investigational Site Memphis Tennessee United States 93104
    24 NeurogesX Investigational Site Austin Texas United States 78758
    25 NeurogesX Investigational Site Dallas Texas United States 75234
    26 NeurogesX Investigational Site San Antonio Texas United States 78229
    27 NeurogesX Investigational Site Salt Lake City Utah United States 84107
    28 NeurogesX Investigational Site Tacoma Washington United States 98405

    Sponsors and Collaborators

    • NeurogesX

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00061776
    Other Study ID Numbers:
    • C108
    First Posted:
    Jun 4, 2003
    Last Update Posted:
    Mar 6, 2008
    Last Verified:
    Mar 1, 2008
    Keywords provided by , ,
    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:
    Herpes Zoster
    Neuralgia
    Nervous System Diseases
    Neuralgia, Postherpetic
    Peripheral Nervous System Diseases
    Capsaicin

    Study Results

    No Results Posted as of Mar 6, 2008