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Trial Consisting of an 8-week Double-blind Placebo-controlled Part to Evaluate Efficacy, Safety, Tolerability and Pharmacokinetics of Prucalopride in Paediatric Subjects With Functional Constipation, Aged ≥6 Months to <18 Years, Followed by a 16-week Open-label Comparator (PEG) Controlled Part, to Document Safety and Tolerability up to 24 Weeks

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Trial Profile

Trial Consisting of an 8-week Double-blind Placebo-controlled Part to Evaluate Efficacy, Safety, Tolerability and Pharmacokinetics of Prucalopride in Paediatric Subjects With Functional Constipation, Aged ≥6 Months to <18 Years, Followed by a 16-week Open-label Comparator (PEG) Controlled Part, to Document Safety and Tolerability up to 24 Weeks

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 Oct 2023

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At a glance

  • Drugs Prucalopride (Primary) ; PEG 4000
  • Indications Constipation
  • Focus Registrational; Therapeutic Use
  • Sponsors Shire; Shire-Movetis NV

Most Recent Events

  • 01 Mar 2013 Status changed from recruiting to completed as reported by ClinicalTrials.gov.
  • 19 Feb 2013 Planned end date changed from 1 Jul 2013 to 1 Mar 2013 as reported by ClinicalTrials.gov.
  • 19 Apr 2012 Planned end date changed from 5 May 2013 to 1 Jul 2013 as reported by ClinicalTrials.gov.

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