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A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multi-Center Study With a Double Blind Extension Investigating the Efficacy and Safety of a Fast- Dissolving ("Melt") Formulation of Desmopressin for the Treatment of Nocturia in Adults

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Trial Profile

A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multi-Center Study With a Double Blind Extension Investigating the Efficacy and Safety of a Fast- Dissolving ("Melt") Formulation of Desmopressin for the Treatment of Nocturia in Adults

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 Jan 2020

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At a glance

  • Drugs Desmopressin (Primary)
  • Indications Nocturia
  • Focus Registrational; Therapeutic Use
  • Sponsors Ferring Pharmaceuticals

    • Most Recent Events

    • 21 Jun 2018 According to a Ferring Pharmaceuticals media release, the U.S. FDA granted Ferring Pharmaceuticals Inc. approval to market NOCDURNA, the first sublingual tablet for the treatment of nocturia due to nocturnal polyuria in adults who awaken at least two times per night to void. The FDA approval of NOCDURNA is based on three double-blind trials (NCT01223937, NCT01262456 and NCT00477490) and one open-label extension trial (NCT00615836, up to three years).
    • 05 Feb 2015 Based on the results of this trial, sublingual desmopressin [Nocdurna] orally disintegrating tablets were approved in Canada for the treatment of nocturia in adults, according to a Ferring Canada media release.
    • 06 Jun 2012 New source identified and integrated (ClinicalTrials.gov: US National Institutes of Health; Parent trial: NCT00477490).
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