Clinical trial NCT00478179: Study of a Bupivacaine Patch (Eladur™) to Treat Post- Herpetic Neuralgia
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postherpetic Neuralgia
Pain
Keywords: herpes zoster
shingles
PHN
post herpetic neuralgia
neuropathic pain
Lead sponsor: Durect
Sponsor class: INDUSTRY
First posted: 2007-05-24
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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™).


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.

Primary outcomes:
measure: Reduction of pain with mean daily pain intensity
Secondary outcomes:
measure: Subject's satisfaction of treatment; Change in neuropathic pain; Patch adherence.
Other outcomes:
Locations:
city: La Jolla
country: United States
state: California
city: Loma Linda
country: United States
state: California
city: Santa Monica
country: United States
state: California
city: Bradenton
country: United States
state: Florida
city: Altoona
country: United States
state: Pennsylvania
city: Salt Lake City
country: United States
state: Utah
city: Tacoma
country: United States
state: Washington
Study officials:
References: