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A Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Quality of Life, Safety and Tolerability of Long-term Treatment (24 Weeks) With Prucalopride in Subjects Aged ≥18 Years With Chronic Constipation.

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Trial Profile

A Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Quality of Life, Safety and Tolerability of Long-term Treatment (24 Weeks) With Prucalopride in Subjects Aged ≥18 Years With Chronic Constipation.

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 22 Dec 2022

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At a glance

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

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 US FDA has a approved Motegrity (prucalopride), a once-daily, oral treatment option for adults with Chronic Idiopathic Constipation (CIC). This approval is based on the five double-blind, placebo-controlled, randomized, multicenter clinical studies lasting 12 weeks phase 3 (studies 1-5) and one 24 week Phase 4 study (study 6).
  • 18 Oct 2018 According to a Shire media release, FDA advisory committee recommended approval of Prucalopride (SHP555) for chronic idiopathic constipation.

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