Study of a Bupivacaine Patch (Eladur™) to Treat Post- Herpetic Neuralgia
Primary Purpose
Postherpetic Neuralgia, Pain
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Transdermal/Patch (Bupivacaine TTS [Eladur™])
Sponsored by
About this trial
This is an interventional treatment trial for Postherpetic Neuralgia focused on measuring herpes zoster, shingles, PHN, post herpetic neuralgia, neuropathic pain
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.
Sites / Locations
Outcomes
Primary Outcome Measures
Reduction of pain with mean daily pain intensity
Secondary Outcome Measures
Subject's satisfaction of treatment; Change in neuropathic pain; Patch adherence.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00478179
Brief Title
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
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Durect
4. Oversight
5. Study Description
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™).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postherpetic Neuralgia, Pain
Keywords
herpes zoster, shingles, PHN, post herpetic neuralgia, neuropathic pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Transdermal/Patch (Bupivacaine TTS [Eladur™])
Primary Outcome Measure Information:
Title
Reduction of pain with mean daily pain intensity
Secondary Outcome Measure Information:
Title
Subject's satisfaction of treatment; Change in neuropathic pain; Patch adherence.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
City
La Jolla
State/Province
California
Country
United States
City
Loma Linda
State/Province
California
Country
United States
City
Santa Monica
State/Province
California
Country
United States
City
Bradenton
State/Province
Florida
Country
United States
City
Altoona
State/Province
Pennsylvania
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States
City
Tacoma
State/Province
Washington
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of a Bupivacaine Patch (Eladur™) to Treat Post- Herpetic Neuralgia
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