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

Condition(s) targeted: Postherpetic Neuralgia; Pain

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

Phase: Phase 2

Status: Recruiting

Sponsored by: Durect

Overall contact:
Judy Johnston, Phone: 408-777-4944, Email: Judy.Johnston@durect.com

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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study

Primary outcome: Reduction of pain with mean daily pain intensity

Secondary outcome: Subject's satisfaction of treatment; Change in neuropathic pain; Patch adherence.

Minimum age: 21 Years. Maximum age: N/A. Gender(s): Both.

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.

Judy Johnston, Phone: 408-777-4944, Email: Judy.Johnston@durect.com

La Jolla, California, United States; Recruiting

Loma Linda, California, United States; Recruiting

Santa Monica, California, United States; Recruiting

Bradenton, Florida, United States; Recruiting

Altoona, Pennsylvania, United States; Recruiting

Salt Lake City, Utah, United States; Recruiting

Tacoma, Washington, United States; Recruiting

Starting date: September 2006
Last updated: May 23, 2007