Who is sponsoring NCT01710787?

NCT01710787 is sponsored by St. Renatus, LLC.

What condition does NCT01710787 study?

NCT01710787 studies Anesthesia.

What drugs are being tested in NCT01710787?

Interventions: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%, Tetracaine HCl 3%, Placebo.

What is the status of NCT01710787?

NCT01710787 is currently COMPLETED.

Last reviewed 2017-07-28 · How we verify

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

NCT01710787 Phase 3 COMPLETED 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	COMPLETED
Enrolment	110
Start date	2012-10
Completion	2013-02

Conditions

Anesthesia

Interventions

Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
Tetracaine HCl 3%
Placebo

Primary outcomes

Number of Participants Who Completed the Study Dental Procedure After Without Need for Rescue by Injection of Local Anesthetic. — at 15 minutes with a 3 minute window
If the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome.

Countries

United States