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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00478179
Recruitment Status : Completed
First Posted : May 24, 2007
Last Update Posted : September 11, 2009
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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™).

Condition or disease Intervention/treatment Phase
Postherpetic Neuralgia Pain Drug: Transdermal/Patch (Bupivacaine TTS [Eladur™]) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : September 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles

Primary Outcome Measures :
  1. Reduction of pain with mean daily pain intensity

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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00478179

United States, California
La Jolla, California, United States
Loma Linda, California, United States
Santa Monica, California, United States
United States, Florida
Bradenton, Florida, United States
United States, Pennsylvania
Altoona, Pennsylvania, United States
United States, Utah
Salt Lake City, Utah, United States
United States, Washington
Tacoma, Washington, United States
Sponsors and Collaborators
Durect Identifier: NCT00478179     History of Changes
Other Study ID Numbers: CLIN005-0009
First Posted: May 24, 2007    Key Record Dates
Last Update Posted: September 11, 2009
Last Verified: September 2009

Keywords provided by Durect:
herpes zoster
post herpetic neuralgia
neuropathic pain

Additional relevant MeSH terms:
Neuralgia, Postherpetic
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents