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

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

Completed
Phase of Trial: Phase III

Latest Information Update: 05 Jun 2015

At a glance

  • Drugs Prucalopride (Primary) ; PEG 4000
  • Indications Constipation
  • Focus Therapeutic Use
  • Sponsors Shire
  • 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.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top