Anesthesia Clinical Trial
Official title:
A Phase 2, Single-Center, Open-Label, Randomized, Parallel-Groups, Dose-Ranging Study to Assess the Efficacy and Safety of Intranasally Administered Kovacaine Mist for Anesthetizing Maxillary Teeth in Pediatric Subjects
The purpose of this study is to assess the efficacy and safety of intranasally administered Kovacaine Mist for anesthetizing maxillary teeth in pediatric subjects.
This is a single-center, open-label, randomized, parallel-groups, dose-ranging study to
assess the efficacy and safety of intranasally administered Kovacaine Mist for anesthetizing
maxillary teeth in pediatric subjects.
The study will employ an open-label design to determine the lowest effective doses (LEDs),
and assess the safety and efficacy of Kovacaine Mist administered intranasally for inducing
pulpal anesthesia of maxillary primary teeth numbers A to J and maxillary permanent teeth
numbers 4 to 13 (maxillary right second premolar to maxillary left second premolar)
sufficient to allow completion of the Study Dental Procedure, and will be carried out in
healthy children of either sex between the ages of 3 and 17 years, inclusive.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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