Pharmacokinetic Study of Synera™ in Neonates and Infants | NCT00747669

Studies
Pharmacokinetic Study of Synera™ in Neonates and Infants

NCT00747669

Sponsor

ZARS Pharma Inc.

Status

Suspended

Last Update Posted

Mar 23, 2012Estimated

Enrollment

11Estimated

Phase

Phase 4

Conditions

Pain

Interventions

lidocaine 70mg and tetracaine 70mg topical 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

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

Mar 2012

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Difficulty with enrollment

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Apr 2013Estimated

Completion Date

Apr 2013Estimated

First Submitted Date

Sep 3, 2008

First Submission Date that Met QC Criteria

Sep 3, 2008

First Posted Date

Sep 5, 2008Estimated

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

Mar 22, 2012

Last Update Posted Date

Mar 23, 2012Estimated

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

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

11Estimated

Name	Type	Description	Arm Group Labels	Other Names
lidocaine 70mg and tetracaine 70mg topical patch	Drug	One Synera Patch applied for 30 minutes.		Synera

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluate the systemic exposure to lidocaine and tetracaine following application of Synera		30 hours

Secondary Outcomes

Measure	Description	Time Frame
Monitor the nature and frequency of adverse events		30 Hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject must be an infant of 1 to 4 months of age and weigh at least 2.5 kg or a neonate of 0 to 4 weeks postnatal age with a gestation period of at least 37 weeks, and weigh at least 1.8 kg.
Subject is scheduled to have a medically indicated minor superficial procedure for which topical local anesthesia would provide a benefit.
Subject has or will have an indwelling vascular access catheter for blood sampling at the time of the procedure visit. The indwelling vascular access catheter placement must be necessary for medical reasons other than the purposes of this study.
The additional blood draws for the purposes of this study do not pose more than a minor risk to the health and welfare of the subject.

Exclusion Criteria:

Subject has known allergies or sensitivities to any component of Synera.
Subject has clinically significant laboratory abnormalities.
Subject has known multiple allergies that could indicate hypersensitive skin.
Subject has known active atopic dermatitis at or near the patch application site.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

4 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
ZARS Clinical Development	ZARS Pharma	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's National Medical Center		Washington D.C.	District of Columbia	20010	United States

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008012	Lidocaine
D013748	Tetracaine
D057968	Transdermal Patch

Ancestor Terms

ID	Term
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814

Browse Leaves

Not provided

Browse Branches

Not provided