Prucalopride in Paediatric Subjects, With Functional Faecal Retention

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Movetis
ClinicalTrials.gov Identifier:
NCT01670669
First received: July 31, 2012
Last updated: August 20, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Constipation
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.

  Eligibility

Ages Eligible for Study:   4 Years to 12 Years
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01670669

Sponsors and Collaborators
Movetis
Investigators
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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Movetis
ClinicalTrials.gov 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:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014