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Single Dose Pharmacokinetics of Prucalopride in Paediatric Subjects, With Functional Faecal Retention

NCT01674166 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2012-08-28

No results posted yet for this study

Summary

The purpose of this study is characterize the pharmacokinetics of a single oral dose of 0.03 mg/kg prucalopride in paediatric subjects aged \>= 4 to \<= 12 years with functional faecal retention.

Hypothesis:

Pharmacokinetic profile of prucalopride in paediatric subjects is expected to resemble the adult pharmacokinetic profile

Conditions

Interventions

DRUG

prucalopride

single dose 0.03 mg/kg prucalopride open label

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
1999-05-31
Completion
1999-05-31

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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 NCT01674166 on ClinicalTrials.gov