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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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™).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study With Lido-Patch and Placebo Plaster in Patients Suffering From Postherpetic Neuralgia (PHN)

NCT03745404

Post Herpetic Neuralgia

COMPLETED PHASE3

Pilot Study of High-Dose Capsaicin Patches to Treat Postherpetic Neuralgia Pain

NCT00034710

Neuralgia Pain Peripheral Nervous System Diseases +1 more

COMPLETED PHASE2

Study of the Efficacy and Safety of Bupivacaine TTS Patch in Patients With Chronic Low Back Pain

NCT01096966

Chronic Low Back Pain

COMPLETED PHASE2

Efficacy and Safety Study of Z160 in Subjects With Postherpetic Neuralgia

NCT01757873

Postherpetic Neuralgia

COMPLETED PHASE2

Multimodal Nerve Block and Pulse Radiofrequency for Acute Herpes Zoster Pain

NCT06798662

Herpes Zoster (HZ)

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postherpetic Neuralgia Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Transdermal/Patch (Bupivacaine TTS [Eladur™])

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No