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
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
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History