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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

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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

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 07 Sep 2017

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At a glance

  • Drugs Oxymetazoline/tetracaine (Primary) ; Tetracaine
  • 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.
    • 05 Jun 2015 Status changed from active, no longer recruiting to discontinued, as reported by ClinicalTrials.gov.
    • 01 Oct 2012 Planned End Date changed from 1 Oct 2012 to 1 Nov 2012 as reported by ClinicalTrials.gov.

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