Expired Study
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La Jolla, California 92037


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).


Study summary:

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.


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.


NCT ID:

NCT00061776


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

La Jolla, California 92037
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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