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

September 9, 2009 updated by: Durect

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

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™).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States
      • Loma Linda, California, United States
      • Santa Monica, California, United States
    • Florida
      • Bradenton, Florida, United States
    • Pennsylvania
      • Altoona, Pennsylvania, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Washington
      • Tacoma, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Reduction of pain with mean daily pain intensity

Secondary Outcome Measures

Outcome Measure
Subject's satisfaction of treatment; Change in neuropathic pain; Patch adherence.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Durect

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

May 22, 2007

First Submitted That Met QC Criteria

May 23, 2007

First Posted (Estimate)

May 24, 2007

Study Record Updates

Last Update Posted (Estimate)

September 11, 2009

Last Update Submitted That Met QC Criteria

September 9, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLIN005-0009

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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