NCT01330381

Prucalopride in Pediatric Subjects With Functional Constipation

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: Phase 3
• Study type: Interventional
• Enrollment: 215 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 6 Months – 17 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy of prucalopride compared to placebo for the treatment of functional constipation in a paediatric population, aged ≥ 6 months to \< 18 years. A 16-week open-label comparator (PEG) controlled part will follow, to document safety and tolerability up to 24 weeks.

Conditions

• Functional Constipation

Interventions

Type	Name	Description
DRUG	prucalopride	prucalopride * subjects with weight ≤50kg: 0.04 mg/kg once daily as oral solution of 0.4 mg/ml * subjects with weight \>50 kg: prucalopride 2 mg tablet once daily
DRUG	Placebo	Matching oral solution or oral tablets given once daily
DRUG	PEG 4000

Timeline

• Start date: 2011-04-28
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2011-04-06
• Last updated: 2021-06-10
• Results posted: 2014-02-26

Locations

1 site across 1 country: Netherlands