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A Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Prucalopride (Resolor) Tablets in Participants With Chronic Constipation

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Trial Profile

A Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Prucalopride (Resolor) Tablets in Participants With Chronic Constipation

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 22 Dec 2022

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At a glance

  • Drugs Prucalopride (Primary)
  • Indications Constipation
  • Focus Therapeutic Use
  • Sponsors Janssen Research & Development

Most Recent Events

  • 26 Oct 2022 Results of post hoc pooled analysis from NCT01147926, NCT01424228, NCT01116206, NCT00483886,NCT0048594011 and NCT004881371; evaluating the effect of renal function on the efficacy and safety of prucalopride, presented at the American College of Gastroenterology Annual Scientific Meeting and Postgraduate Course 2022
  • 17 Dec 2018 According to a Shire media release, the U.S. Food and Drug Administration (FDA) has approved Motegrity (prucalopride) once-daily oral treatment for adults with Chronic Idiopathic Constipation (CIC). The FDA has requested that Shire conduct five post-marketing studies evaluating the pharmacokinetics, efficacy, and safety of Motegrity in pediatric patients with CIC (6 months old to less than 18 years of age) and pregnant and lactating women with CIC treated with Motegrity.
  • 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.

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