Who is sponsoring NCT01701505?

NCT01701505 is sponsored by St. Renatus, LLC.

What condition does NCT01701505 study?

NCT01701505 studies Anesthesia.

What drugs are being tested in NCT01701505?

Interventions: 400uL of Kovacaine Mist, 200uL of Kovacaine Mist, 120uL of Kovacaine Mist.

What is the status of NCT01701505?

NCT01701505 is currently COMPLETED.

Last reviewed 2017-07-28 · How we verify

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

NCT01701505 Phase 2 COMPLETED Results posted

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

Details

Lead sponsor	St. Renatus, LLC
Phase	Phase 2
Status	COMPLETED
Enrolment	48
Start date	2012-10
Completion	2012-10

Conditions

Anesthesia

Interventions

400uL of Kovacaine Mist
200uL of Kovacaine Mist
120uL of Kovacaine Mist

Primary outcomes

Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic. — at 14 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