Expired Study
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Melbourne, Florida 32935


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.


Study is Available At:


Original ID:

C108


NCT ID:

NCT00061776


Secondary ID:


Study Acronym:


Brief Title:

NGX-4010 for the Treatment of Postherpetic Neuralgia


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 2/Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

NeurogesX


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

300


Enrollment Type:


Study Dates

Verification Date:March 2008
Last Changed Date:March 4, 2008
First Received Date:June 3, 2003

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Capsaicin Dermal Patch

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:NeurogesX

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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