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

This study has been completed.
Sponsor:
Information provided by:
Durect
ClinicalTrials.gov Identifier:
NCT00478179
First received: May 22, 2007
Last updated: September 9, 2009
Last verified: September 2009
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Durect:

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.

Enrollment: 60
Study Start Date: September 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00478179

Locations
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00478179     History of Changes
Other Study ID Numbers: CLIN005-0009
Study First Received: May 22, 2007
Last Updated: September 9, 2009
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 01, 2014