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Prucalopride in Paediatric Subjects, With Functional Faecal Retention

NCT01670669 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2012-08-22

No results posted yet for this study

Summary

The purpose of this study is characterize the efficacy, safety, tolerability, and steady-state plasma levels after once-daily oral dosing of prucalopride (R108512) as a solution, 0.01 mg/kg to 0.03 mg/kg, given to paediatric subjects with functional faecal retention (FFR) for 8 weeks.

Hypothesis:

Pharmacokinetic profile of prucalopride in paediatric subjects is expected to resemble the adult pharmacokinetic profile. Safety and tolerability profile are expected to resemble the adult profile.

Conditions

Interventions

DRUG

prucalopride

0.01 mg/kg/day to 0.03 mg/kg/day prucalopride (R108512) oral solution

Sponsors & Collaborators

  • Movetis

    lead INDUSTRY

Principal Investigators

  • Harald Winter, M.D. · Massachusetts General Hospital for Children, Boston, Massachusetts, USA

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
12 Years
Sex
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-11-30
Primary Completion
1999-07-31
Completion
1999-07-31

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Entities

Diseases

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 NCT01670669 on ClinicalTrials.gov