Study Stopped
Difficulty with enrollment
Pharmacokinetic Study of Synera™ in Neonates and Infants
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
1 other identifier
interventional
11
1 country
1
Brief Summary
This study will measure the amount of lidocaine and tetracaine in the blood after a 30 minute application of Synera.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 pain
Started Sep 2008
Longer than P75 for phase_4 pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 3, 2008
CompletedFirst Posted
Study publicly available on registry
September 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedMarch 23, 2012
March 1, 2012
4.6 years
September 3, 2008
March 22, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluate the systemic exposure to lidocaine and tetracaine following application of Synera
30 hours
Secondary Outcomes (1)
Monitor the nature and frequency of adverse events
30 Hours
Interventions
One Synera Patch applied for 30 minutes.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ZARS Pharma Inc.lead
Study Sites (1)
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
ZARS Clinical Development
ZARS Pharma
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 3, 2008
First Posted
September 5, 2008
Study Start
September 1, 2008
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
March 23, 2012
Record last verified: 2012-03