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A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel-group Trial With an Open-label Extension to Demonstrate the Efficacy and Safety of Desmopressin Orally Disintegrating Tablets for the Treatment of Nocturia in Adult Males

Trial Profile

A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel-group Trial With an Open-label Extension to Demonstrate the Efficacy and Safety of Desmopressin Orally Disintegrating Tablets for the Treatment of Nocturia in Adult Males

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 26 Sep 2018

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At a glance

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

    • 31 Aug 2018 Results of a responder analysis in subgroup of patients with nocturnal polyuria in two phase III trials (NCT01262456 and NCT01223937) presented at the 48th Annual Meeting of the International Continence Society
    • 31 Aug 2018 Results of a post-hoc analysis assessing efficacy and safety of desmopressin in subgroup of patients with nocturia and nocturnal polyuria in two phase III trials (NCT01262456 and NCT01223937) presented at the 48th Annual Meeting of the International Continence Society
    • 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).
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