Prucalopride in Paediatric Subjects, With Functional Faecal Retention

Overview

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.

Full Title of Study: “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.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 1999

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.

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: prucalopride
    • 0.01 mg/kg/day to 0.03 mg/kg/day prucalopride (R108512) oral solution

Clinical Trial Outcome Measures

Primary Measures

  • Adverse events
  • Efficacy

Secondary 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 4 Years

Maximum Age: 12 Years

Investigator Details

  • Lead Sponsor
    • Movetis
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Harald Winter, M.D., Principal Investigator, Massachusetts General Hospital for Children, Boston, Massachusetts, USA

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