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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00478179
• Other study ID #: CLIN005-0009
• Status: Completed
• Phase: Phase 2
• First received: May 22, 2007
• Last updated: September 9, 2009
• Start date: September 2006
• Est. completion date: December 2007

Study information

• Verified date: September 2009
• Source: Durect
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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™).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuralgia
• Neuralgia, Postherpetic
• Pain
• Postherpetic Neuralgia

Intervention

Drug:
• Transdermal/Patch (Bupivacaine TTS [Eladur™])

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Durect

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of pain with mean daily pain intensity
Secondary	Subject's satisfaction of treatment; Change in neuropathic pain; Patch adherence.