NCT Number: NCT00478179
Study of a Bupivacaine Patch (Eladur™) to Treat Post- Herpetic Neuralgia
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™).
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Notify MeKey information
Conditions
Age range
21 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
La Jolla, California, United States
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Male or females age 21 years or older.
- Pain in thoracic or lumbar regions for a minimum of 90 days after crusting of Herpes Zoster (HZ) lesions.
- Stable prescribed medications regimen (including opioids, anticonvulsants, and tricyclic antidepressants).
- Intact, unbroken skin over the painful area to be treated.
- Body Mass Index (BMI) no more than 35 kg/m2.
Exclusion criteria
- Active HZ lesions, dermatitis, Central Nervous System (CNS) injury.
- Any immunosuppressed condition, including but not limited to AIDS/HIV and Hodgkin's lymphoma.
- Pain control by nerve block or neurosurgical intervention.
- Evidence of clinically significant hepatic, gastrointestinal, renal, hematologic, urologic, neurologic, respiratory, endocrine or cardiovascular system abnormalities, psychiatric disorders, or acute infection.
- Connective tissue disorders (systemic lupus erythematosus, scleroderma, mixed connective tissue disease).
- Recent use (within 30 days preceding the first treatment visit) of any topically applied pain medication, such as nonsteroidal anti-inflammatory drugs, menthol, methyl salicylate, local anesthetics (including Lidoderm®), steroids or capsaicin products on the painful areas.
- Significant pain of an etiology other than PHN, for example, compression-related neuropathies (e.g., spinal stenosis), fibromyalgia or arthritis. Patients must not have significant ongoing pain from other cause(s) that may interfere with judging PHN related pain.
- Participation in a clinical trial of an investigational product or device within 30 days of the screening visit or concurrently during the conduct of this study.
Treatment and study plan
Primary outcomes
-
Reduction of pain with mean daily pain intensity
Secondary outcomes
-
Subject's satisfaction of treatment; Change in neuropathic pain; Patch adherence.
Sponsors and collaborators
Lead sponsor
Durect
Industry
Registry information
Official study 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
Important dates
- Study start
- 2006
- Primary completion
- 2007
- Study completion
- 2007
- First posted
- May 24, 2007
- Registry last updated
- Sep 11, 2009
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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