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
Phase of Trial: Phase III
Latest Information Update: 01 Sep 2017
At a glance
- Drugs Oxymetazoline/tetracaine (Primary)
- Indications Dental pain; Procedural pain
- Focus Registrational; Therapeutic Use
- Sponsors St. Renatus
- 12 Jul 2016 According to a St. Renatus media release, KOVANAZE (tetracaine HCl and oxymetazoline HCl) nasal spray has been approved by the US FDA for use in dentistry.
- 01 Jul 2013 Status changed from not yet recruiting to completed as reported by ClinicalTrials.gov.
- 08 May 2013 Planned initiation date changed from 1 Jun 2011 to 1 May 2013, as reported by ClinicalTrials.gov.