Study of a Bupivacaine Patch (Eladur™) to Treat Post- Herpetic Neuralgia

Study Overview
=================
Brief Summary
-----------------
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™).

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

Conditions
-----------------
Pain, Postherpetic Neuralgia

Intervention / Treatment
-----------------
* Drug: Transdermal/Patch (Bupivacaine TTS [Eladur™])


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Transdermal/Patch (Bupivacaine TTS [Eladur™])|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of pain with mean daily pain intensity |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject's satisfaction of treatment; Change in neuropathic pain; Patch adherence. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
herpes zoster, shingles, PHN, post herpetic neuralgia, neuropathic pain