A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Demonstrate the Efficacy and Safety of Desmopressin Orally Disintegrating Tablet for the Treatment of Nocturia in Adult Females

Trial Profile

A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Demonstrate the Efficacy and Safety of Desmopressin Orally Disintegrating Tablet for the Treatment of Nocturia in Adult Females

Completed
Phase of Trial: Phase III

Latest Information Update: 01 Nov 2016

At a glance

  • Drugs Desmopressin (Primary)
  • Indications Nocturia
  • Focus Registrational; Therapeutic Use
  • Acronyms COMFORT
  • Sponsors Ferring Pharmaceuticals
  • Most Recent Events

    • 01 Nov 2016 According to Ferring Pharmaceuticals media release, based on the result of this trial, NOQDIRNA (oral lyophilisate desmopressin) has been approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA).
    • 03 May 2016 According to a Ferring Pharmaceuticals media release, NOCDURNA was reviewed via the Decentralised Procedure (DCP) with the Swedish Medical Products Agency (MPA) acting as the Reference Member State (RMS).
    • 03 May 2016 According to a Ferring Pharmaceuticals media release, desmopressin [Nocdurna] has been approved in the European Union for the symptomatic treatment of nocturia due to idiopathic nocturnal polyuria in adults based on results from this trial.
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