Prucalopride in Pediatric Subjects With Functional Constipation

PHASE3CompletedINTERVENTIONAL
Enrollment

215

Participants

Timeline

Start Date

April 28, 2011

Primary Completion Date

March 1, 2013

Study Completion Date

March 1, 2013

Conditions
Functional Constipation
Interventions
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

Trial Locations (1)

1105 AZ

Academisch Medisch Centrum, Amsterdam

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

PRA Health Sciences

INDUSTRY

lead

Shire

INDUSTRY