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

Trial Profile

A Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of R108512 Tablets in Subjects 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 Registrational; Therapeutic Use
  • Sponsors 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
    • 28 Oct 2020 Results of a post hoc analysis from NCT01147926; NCT00485940 ; NCT00483886; NCT00488137 and other studies assessing assess the effect of prucalopride on abdominal bloating, presented at the American College of Gastroenterology Annual Scientific Meeting and Postgraduate Course 2020
    • 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.
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