Study of a Bupivacaine Patch (Eladur™) to Treat Post- Her... | NCT00478179

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

NCT00478179

Sponsor

Durect

Status

Completed

Last Update Posted

Sep 11, 2009Estimated

Enrollment

60Actual

Phase

Phase 2

Conditions

Postherpetic Neuralgia
Pain

Interventions

Transdermal/Patch (Bupivacaine TTS [Eladur™])

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Dec 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

May 22, 2007

First Submission Date that Met QC Criteria

May 23, 2007

First Posted Date

May 24, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Sep 9, 2009

Certification/Extension First Submitted that Passed QC Review

Sep 9, 2009

Certification/Extension First Posted Date

Sep 11, 2009Estimated

Last Update Submitted Date

Sep 9, 2009

Last Update Posted Date

Sep 11, 2009Estimated

Description Module

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™).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Name	Type	Description	Arm Group Labels	Other Names
Transdermal/Patch (Bupivacaine TTS [Eladur™])	Drug

Measure	Description	Time Frame
Reduction of pain with mean daily pain intensity

Measure	Description	Time Frame
Subject's satisfaction of treatment; Change in neuropathic pain; Patch adherence.

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		La Jolla	California		United States

ID	Term
D051474	Neuralgia, Postherpetic
D010146	Pain
D006562	Herpes Zoster
D009437	Neuralgia

ID	Term
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D009461	Neurologic Manifestations

ID	Term
D000279	Administration, Cutaneous
D057968	Transdermal Patch

ID	Term
D000287	Administration, Topical
D004333	Drug Administration Routes
D004358	Drug Therapy
D013812	Therapeutics