A Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Prucalopride (R108512) Tablets in Subjects With Chronic Constipation.

Trial Profile

A Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Prucalopride (R108512) Tablets in Subjects With Chronic Constipation.

Completed
Phase of Trial: Phase III

Latest Information Update: 09 May 2017

At a glance

  • Drugs Prucalopride (Primary)
  • Indications Constipation
  • Focus Registrational; Therapeutic Use
  • Sponsors Shire-Movetis NV
  • Most Recent Events

    • 09 May 2017 Results assessing the minimum clinically important difference and an optimum PAC-SYM cut-off score for defining responders using week 4 data (n=2884) from six phase 3 and 4 trials of prucalopride in chronic constipation (NCT01147926, NCT01424228, NCT01116206, NCT00485940, NCT00483886, NCT00488137), presented at the Digestive Disease Week 2017.
    • 03 Sep 2010 Swissmedic granted marketing authorisation of Resolor for treatment of idiopathic chronic constipation in adults, based on this results of this and 2 other pivotal trials, according to a Movetis media release.
    • 06 May 2010 Results of a pooled analysis of all three pivotal phase III trials and their long-term follow up have been presented at the conference Digestive Disease Week 2010.
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