A Randomized, Double Blind, Placebo Controlled, Multicenter Study to Investigate the Efficacy and Safety of SER120 Nasal Spray Formulation in Patients With Nocturia

Trial Profile

A Randomized, Double Blind, Placebo Controlled, Multicenter Study to Investigate the Efficacy and Safety of SER120 Nasal Spray Formulation in Patients With Nocturia

Completed
Phase of Trial: Phase III

Latest Information Update: 20 May 2017

At a glance

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

    • 20 May 2017 Results of a pooled analysis of the NCT01357356 and NCT01900704 assessing efficacy/safety of SER120 1.5 mcg and 0.75 mcg, in nocturia patients (pts) more than or equal to 65 yrs of age, presented at the 2017 Annual Scientific Meeting of the American Geriatrics Society
    • 06 Mar 2017 According to a Serenity Pharmaceuticals Corporation media release, based on the data from this and another phase III study (profile 700220259), the U.S. Food and Drug Administration (FDA) approved Noctiva™ (desmopressin acetate) nasal spray for the treatment of nocturia due to nocturnal polyuria in adults who awaken two or more times per night to urinate.
    • 16 Sep 2016 Results of pooled analysis of DB3 and DB4 studies presented at the 46th Annual Meeting of the International Continence Society.
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