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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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 01 Sep 2017

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At a glance

  • Drugs Oxymetazoline/tetracaine (Primary)
  • Indications Dental pain; Procedural pain
  • Focus Registrational; Therapeutic Use
  • Sponsors St. Renatus

Most Recent Events

  • 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.

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