Ignite Creation Date:
2025-12-17 @ 4:06 PM
Ignite Modification Date:
2025-12-23 @ 11:01 PM
Study NCT ID:
NCT00747669
Status:
SUSPENDED
Last Update Posted:
2012-03-23
First Post:
2008-09-03
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Study of Synera™ in Neonates and Infants
Sponsor:
ZARS Pharma Inc.
Organization:
Study Overview
Official Title:
A Pharmacokinetic Study of Synera™ (Lidocaine 70 mg and Tetracaine 70 mg Topical Patch) to Evaluate the Systemic Exposure to Lidocaine and Tetracaine in Neonates and Infants
Status:
SUSPENDED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulty with enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will measure the amount of lidocaine and tetracaine in the blood after a 30 minute application of Synera.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: