Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Durect |
---|---|
Information provided by: | Durect |
ClinicalTrials.gov Identifier: | NCT00478179 |
Neuropathic pain is caused by a virus commonly associated with chicken pox. This virus may become dormant in the nervous system and later reactivate causing herpes zoster, also known as "shingles". Post-herpetic neuralgia (PHN) is a persistent pain in the area of healed skin lesions. This study will test the safety and efficacy of treating PHN patients with the analgesic patch, Bupivacaine TTS (Eladur™).
Condition | Intervention | Phase |
---|---|---|
Postherpetic Neuralgia Pain |
Drug: Transdermal/Patch (Bupivacaine TTS [Eladur™]) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo Controlled, Two-Way Cross-Over Study of Analgesic Efficacy of Bupivacaine Transdermal Therapeutic System in Patients With Post-Herpetic Neuralgia |
Enrollment: | 60 |
Study Start Date: | September 2006 |
Study Completion Date: | December 2007 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients must not have significant ongoing pain from other cause(s) that may interfere with judging PHN related pain.
United States, California | |
La Jolla, California, United States | |
Loma Linda, California, United States | |
Santa Monica, California, United States | |
United States, Florida | |
Bradenton, Florida, United States | |
United States, Pennsylvania | |
Altoona, Pennsylvania, United States | |
United States, Utah | |
Salt Lake City, Utah, United States | |
United States, Washington | |
Tacoma, Washington, United States |
Study ID Numbers: | CLIN005-0009 |
Study First Received: | May 22, 2007 |
Last Updated: | January 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00478179 History of Changes |
Health Authority: | United States: Food and Drug Administration |
herpes zoster shingles PHN post herpetic neuralgia neuropathic pain |
Herpes Zoster Neuralgia, Postherpetic Neuralgia Anesthetics Central Nervous System Depressants Pain Anesthetics, Local |
Signs and Symptoms Neuromuscular Diseases Peripheral Nervous System Diseases Neurologic Manifestations Bupivacaine Peripheral Nervous System Agents Analgesics |
Neuralgia, Postherpetic Neuralgia Nervous System Diseases Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Pain Pharmacologic Actions Anesthetics, Local |
Signs and Symptoms Neuromuscular Diseases Sensory System Agents Therapeutic Uses Peripheral Nervous System Diseases Neurologic Manifestations Bupivacaine Peripheral Nervous System Agents Central Nervous System Agents |