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Sponsored by: |
NeurogesX |
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Information provided by: | NeurogesX |
ClinicalTrials.gov Identifier: | NCT00300222 |
The purpose of the study is to assess the efficacy and safety of NGX-4010 applied for 60 minutes for the treatment of postherpetic neuralgia (PHN).
Condition | Intervention | Phase |
---|---|---|
Peripheral Nervous System Diseases Pain Neuralgia Herpes Zoster Shingles |
Drug: NGX-4010 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter Randomized, Double-Blind, Controlled Study of NGX-4010 for the Treatment of Postherpetic Neuralgia |
Estimated Enrollment: | 400 |
Study Start Date: | March 2006 |
Study Completion Date: | August 2007 |
This study is a 12-week randomized, double-blind, controlled multi-center evaluation of the efficacy, safety and tolerability of NGX-4010 for the treatment of PHN. Eligible subjects will have pain from PHN, with average numeric pain rating scale (NPRS) scores during screening of 3 to 9 (inclusive).
Painful areas of up to 1000 square centimeters will be treated during a single treatment administration in this study. Subjects will be randomly assigned to receive active NGX-4010 patches or low-concentration control patches that are identical in appearance, according to a 1:1 allocation scheme.
Subjects may be on stable chronic oral pain medication regimens, but currently will not be using any topical pain medications on the affected areas. NPRS scores for the average pain in the past 24 hours will be recorded daily in the evening, beginning on the day of the Screening Visit (usually on Day -14).
Subjects will continue to record NPRS scores in a take-home diary from the evening on the day of treatment through the evening before the Termination Visit at Week 12. Subjects will return for interim follow-up visits at Weeks 4 and 8 following study treatment.
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | C117 |
Study First Received: | March 6, 2006 |
Last Updated: | March 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00300222 History of Changes |
Health Authority: | United States: Food and Drug Administration |
dermal assessment pain measurement diary PHN shingles |
neuropathy analgesics capsaicin PHN postherpetic neuralgia |
Herpes Zoster Neuralgia, Postherpetic Neuralgia Pain Capsaicin Herpesviridae Infections Virus Diseases |
Signs and Symptoms Neuromuscular Diseases Peripheral Nervous System Diseases Neurologic Manifestations DNA Virus Infections Analgesics |
Virus Diseases Neuralgia, Postherpetic Herpes Zoster Signs and Symptoms Neuromuscular Diseases Neuralgia |
Peripheral Nervous System Diseases Nervous System Diseases Neurologic Manifestations Pain DNA Virus Infections Herpesviridae Infections |