MedTrace Logo

Prucalopride in Pediatric Subjects With Functional Constipation

NCT01330381 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 215

Last updated 2021-06-10

Study results available
· View outcomes & findings →

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

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

Sponsors & Collaborators

  • PRA Health Sciences

    collaborator INDUSTRY

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-28
Primary Completion
2013-03-01
Completion
2013-03-01

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01330381 on ClinicalTrials.gov