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| 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 |
| 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 |
| Estimated Enrollment: | 300 |
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 |
Key Eligibility Criteria:
Contacts and Locations![]() |
Show 28 Study Locations |
| 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 |
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