NCT01701505

Dose-Ranging Study of Intranasal Kovacaine Mist in Pediatric Subjects

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: St. Renatus, LLC · Industry
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the efficacy and safety of intranasally administered Kovacaine Mist for anesthetizing maxillary teeth in pediatric subjects.

Detailed description

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.

Conditions

• Anesthesia

Interventions

Type	Name	Description
DRUG	400uL of Kovacaine Mist	2 unilateral intranasal sprays of 200uL each.
DRUG	200uL of Kovacaine Mist	2 unilateral intranasal sprays of 100uL each.
DRUG	120uL of Kovacaine Mist	2 unilateral intranasal sprays of 60uL each.

Timeline

• Start date: 2012-10-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2012-10-05
• Last updated: 2017-08-30
• Results posted: 2017-08-30

Locations

1 site across 1 country: United States