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Phase 3, Multicenter, Randomized Study With 2 Different Doses of Prucalopride Administered to Male and Female Pediatric Subjects Aged 6 Months to 17 Years With Functional Constipation, Consisting of a 12-week Double-blind, Placebo-controlled Part (Part A) to Evaluate Efficacy and Safety Followed by a 36-week Double-blind Extension Part (Part B) to Document Long-term Safety up to Week 48

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Phase 3, Multicenter, Randomized Study With 2 Different Doses of Prucalopride Administered to Male and Female Pediatric Subjects Aged 6 Months to 17 Years With Functional Constipation, Consisting of a 12-week Double-blind, Placebo-controlled Part (Part A) to Evaluate Efficacy and Safety Followed by a 36-week Double-blind Extension Part (Part B) to Document Long-term Safety up to Week 48

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 14 Jun 2024

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At a glance

  • Drugs Prucalopride (Primary)
  • Indications Constipation
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Takeda

    • Most Recent Events

    • 10 May 2024 primary endpoints for safety added newly.
    • 19 Dec 2023 Status changed from active, no longer recruiting to discontinued. (Reason the study was stopped:Data Monitoring Committee (DMC) decision; terminated due to futility, with no safety concerns;FDA agreement to terminate the study.)
    • 09 Oct 2023 Status changed from recruiting to active, no longer recruiting.

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