Pain, Postherpetic Neuralgia
Conditions
Keywords
herpes zoster, shingles, PHN, post herpetic neuralgia, neuropathic pain
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™).
Interventions
DRUGTransdermal/Patch (Bupivacaine TTS [Eladur™])
Sponsors
Durect
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of pain with mean daily pain intensity | — |
Secondary
| Measure | Time frame |
|---|---|
| Subject's satisfaction of treatment; Change in neuropathic pain; Patch adherence. | — |
Countries
United States
Outcome results
None listed