Who is sponsoring NCT01844830?

NCT01844830 is sponsored by St. Renatus, LLC.

What condition does NCT01844830 study?

NCT01844830 studies Anesthesia.

What drugs are being tested in NCT01844830?

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

What is the status of NCT01844830?

NCT01844830 is currently COMPLETED.

Last reviewed 2017-07-28 · How we verify

A Phase 3, Multi-Center, Randomized, Double-Blind, Parallel-Groups Clinical Trial Comparing The Efficacy And Safety Of Intranasally Administered Kovacaine Mist To Placebo For Anesthetizing Maxillary Teeth In Pediatric Patients

NCT01844830 Phase 3 COMPLETED Results posted

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

Details

Lead sponsor	St. Renatus, LLC
Phase	Phase 3
Status	COMPLETED
Enrolment	90
Start date	2013-05
Completion	2013-07

Conditions

Anesthesia

Interventions

Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
Placebo

Primary outcomes

Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic. — 100µL dose - at 10 minutes, +3 minute window; for subjects who receive the 200µL or 400µL dose - at 15 minutes, +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