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
Phase of Trial: Phase III
Latest Information Update: 01 Sep 2017
At a glance
- Drugs Oxymetazoline/tetracaine (Primary) ; Tetracaine
- 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 Feb 2013 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
- 06 Dec 2012 Planned End Date changed from 1 Dec 2012 to 1 Jan 2013, according to ClinicalTrials.gov.