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

Trial Profile

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

Completed
Phase of Trial: Phase III

Latest Information Update: 12 Jul 2016

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.
    • 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.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top