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Sponsored by: |
NeurogesX |
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Information provided by: | NeurogesX |
ClinicalTrials.gov Identifier: | NCT00061776 |
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 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Key Eligibility Criteria:
Study ID Numbers: | C108 |
Study First Received: | June 3, 2003 |
Last Updated: | March 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00061776 History of Changes |
Health Authority: | United States: Food and Drug Administration |
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 |
Herpes Zoster Neuralgia, Postherpetic Neuralgia Pain Capsaicin Herpesviridae Infections Virus Diseases Signs and Symptoms |
Neuromuscular Diseases Peripheral Nervous System Diseases Antipruritics Neurologic Manifestations DNA Virus Infections Peripheral Nervous System Agents Analgesics |
Herpes Zoster Neuralgia, Postherpetic Neuralgia Physiological Effects of Drugs Nervous System Diseases Pain Capsaicin Pharmacologic Actions Herpesviridae Infections Virus Diseases |
Signs and Symptoms Neuromuscular Diseases Sensory System Agents Therapeutic Uses Peripheral Nervous System Diseases Antipruritics Neurologic Manifestations DNA Virus Infections Peripheral Nervous System Agents Dermatologic Agents |