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Prucalopride in Paediatric Subjects, With Functional Faecal Retention

This study has been completed.
Information provided by (Responsible Party):
Movetis Identifier:
First received: July 31, 2012
Last updated: August 20, 2012
Last verified: August 2012

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.


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.

Condition Intervention Phase
Drug: prucalopride
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Follow-up Study of 0.01 mg/kg/Day to 0.03 mg/kg/Day Prucalopride (R108512) Oral Solution in Paediatric Subjects, Aged >= 4 to <= 12 Years With Functional Faecal Retention (FFR), Who Participated in the PRU-USA-12.

Resource links provided by NLM:

Further study details as provided by Movetis:

Primary Outcome Measures:
  • Adverse events [ Designated as safety issue: No ]

    Adverse events (AEs) to be recorded by spontanous reporting or after non-leading questioning i.e. reporting of all AEs and its duration during the course of the trial. In addition at bi-weekly visits laboratory assessments, vitals signs, ECGs and physical examinations, reported as mean values and clinical significant abnormalities to be tabulated.

    Efficacy: reporting of bowel movements and its characteristics in a diary.

  • Efficacy [ Designated as safety issue: No ]
    Reporting of bowel movement frequency, i.e. average number of bowel movements on a weekly base.

Secondary Outcome Measures:
  • Secondary efficacy variables: 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. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: November 1998
Study Completion Date: July 1999
Primary Completion Date: July 1999 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: prucalopride
0.01 mg/kg/day to 0.03 mg/kg/day prucalopride (R108512) oral solution
Drug: prucalopride
0.01 mg/kg/day to 0.03 mg/kg/day prucalopride (R108512) oral solution

Detailed Description:

This is a multicentre, open-label trial in which paediatric subjects (ages 4 to 12 years) with FFR were administered prucalopride in oral solution once daily for 8 weeks. Subjects who entered this extension trial had completed PRU-USA-12, a single-dose pharmacokinetic trial, usually within the previous week.

Evaluations for efficacy, safety and tolerability were performed, and plasma samples for analysis of prucalopride levels were obtained at 2, 4, 6 and 8 weeks.

The initial dosage of prucalopride oral solution was 0.02 mg/kg/day. Dependent on the subject's response, the parent could adjust the dosage within a range of 0.01 mg/kg/day to 0.03 mg/kg/day.


Ages Eligible for Study:   4 Years to 12 Years

Inclusion Criteria:

  • Subject completed the PRU-USA-12 pharmacokinetic trial
  • Subject bowels had been "cleaned-out" (ie, any faecal impactions removed)
  • Written informed consent, signed by the subject's legal guardian and by the investigator
  • Subject assent documented in the form of a note-to-file in the subject's source documentation

Exclusion Criteria:

• No exclusion criteria

  Contacts and Locations
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Please refer to this study by its identifier: NCT01670669

Sponsors and Collaborators
Principal Investigator: Harald Winter, M.D. Massachusetts General Hospital for Children, Boston, Massachusetts, USA
  More Information

No publications provided by Movetis

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Movetis Identifier: NCT01670669     History of Changes
Other Study ID Numbers: PRU-USA-24
Study First Received: July 31, 2012
Last Updated: August 20, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Signs and Symptoms
Signs and Symptoms, Digestive processed this record on February 25, 2015