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

NCT01660893 Phase 3 TERMINATED Results posted

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.

Details

Lead sponsor	St. Renatus, LLC
Phase	Phase 3
Status	TERMINATED
Enrolment	26
Start date	2012-08
Completion	2012-09

Conditions

• Anesthesia

Interventions

• Tetracaine HCl 3% and oxymetazoline HCl 0.05%
• Tetracaine HCl 3%
• Placebo

Primary outcomes

• Completion of the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic (Yes/no). — at 15 minutes with a 3 minute window

Countries

United States