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

Durect

Status and phase

Completed

Phase 2

Conditions

Postherpetic Neuralgia

Pain

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00478179

CLIN005-0009

Details and patient eligibility

About

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™).

Enrollment

60 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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.