NCT01660893

Comparison of Intranasal Kovacaine Mist, Tetracaine Alone, and Placebo for Anesthetizing Maxillary Teeth

A Phase III, Multi-Center, Randomized, Double-Blind, Parallel-Groups Clinical Trial Comparing the Efficacy and Safety of Intranasally Administered Kovacaine Mist to Tetracaine Alone and to Placebo for Anesthetizing Maxillary Teeth in Adults

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: St. Renatus, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the efficacy of Kovacaine Mist, Tetracaine only, and Placebo for inducing pulpal anesthesia of the maxillary teeth in adults.

Detailed description

The study will employ a multi-center, randomized, double-blind, placebo-controlled, parallel-groups design to assess the safety and efficacy of Kovacaine Mist delivered intranasally for inducing pulpal anesthesia of maxillary teeth numbers 4 to 13 (maxillary right second premolar to maxillary left second premolar) sufficient to allow completion of the Study Dental Procedure. A total of 140 subjects, randomized 2:2:1 (Kovacaine Mist:Tetracaine alone:Placebo) will be enrolled to achieve 125 completed subjects; a total of 50 Kovacaine Mist subjects, 50 tetracaine alone subjects and 25 placebo subjects. Recruitment will be from diverse dental patient populations. At the two study sites, a balanced enrollment of 70 subjects each is planned to allow for a potential 10% drop-out rate.

Conditions

• Anesthesia

Interventions

Type	Name	Description
DRUG	Tetracaine HCl 3% and oxymetazoline HCl 0.05%	3 unilateral intranasal sprays per dose
DRUG	Tetracaine HCl 3%	3 unilateral intranasal sprays per dose
DRUG	Placebo	3 unilateral intranasal sprays per dose

Timeline

• Start date: 2012-08-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2012-08-09
• Last updated: 2017-09-05
• Results posted: 2017-09-05

Locations

3 sites across 1 country: United States