Evaluate the Depth and Duration of Anesthesia | NCT00891163

Studies
Evaluate the Depth and Duration of Anesthesia

NCT00891163

Sponsor

ZARS Pharma Inc.

Status

Completed

Last Update Posted

May 1, 2009Estimated

Enrollment

25Actual

Phase

Phase 4

Conditions

Pain

Interventions

Synera™ Topical Patch (70 mg lidocaine/70 mg tetracaine)
Placebo Patch

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 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

Dec 2006

Primary Completion Date

Apr 2007Actual

Completion Date

Apr 2007Actual

First Submitted Date

Apr 29, 2009

First Submission Date that Met QC Criteria

Apr 30, 2009

First Posted Date

May 1, 2009Estimated

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

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 30, 2009

Last Update Posted Date

May 1, 2009Estimated

Name	Class
Endo USA Inc., a Keenova Therapeutics Company	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the study is to determine the depth (mm) of anesthesia provided by the Synera topical patch (using sensory depth and pain depth evaluations), and to determine the duration (minutes) of anesthesia provided by the Synera topical patch (using dermal sensory testing and thermal sensory testing evaluations), compared with a matching heated placebo patch.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Synera	Experimental		Drug: Synera™ Topical Patch (70 mg lidocaine/70 mg tetracaine)
Placebo	Placebo Comparator		Drug: Placebo Patch

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Synera™ Topical Patch (70 mg lidocaine/70 mg tetracaine)	Drug	30 minute applicable on antecubital fossa	Synera

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sensory and pain depth measurements		0, 30, 60, 90, 120 and 150 minutes
Dermal and thermal sensory testing evaluations		0, 30, 60, 90, 120 and 150 minutes

Secondary Outcomes

Measure	Description	Time Frame
Assess the safety and tolerability of the Synera topical patch compared with a matching heated placebo patch		Throughout the study
Evaluate local effects on the skin at the site of patch application for dermal adverse events (AEs)		Throughout the study

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Had no known significant diseases
Normal 12-lead electrocardiogram
Willing to refrain from using any local topical preparations

Exclusion Criteria:

Taken over-the-counter (OTC) or prescription analgesics in any form within 24 hours
Known allergy or sensitivity to any component of the Synera patch, including lidocaine, sympathomimetic amines, other local anesthetics of the amide type, epinephrine, or other patch components
Had an active dermatological disease of any origin that may have interfered with their ability to participate

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UCSD Medical Center, Thornton Hospital		San Diego	California	92037-7651	United States

Type	Date	Date Unknown
Release	Mar 22, 2012
Reset	Apr 17, 2012
Release	May 16, 2012
Reset	Jun 14, 2012
Release	Jun 25, 2012
Reset	Jul 25, 2012

Submission Tracking

Estimated Results First Submitted Date

Mar 22, 2012

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Mar 22, 2012			Apr 17, 2012
May 16, 2012

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain
D000377	Agnosia

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D010468	Perceptual Disorders

Browse Leaves

Not provided

Browse Branches

Not provided