A Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of R108512 Tablets in Subjects With Chronic Constipation
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
- 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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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History