Prucalopride in Paediatric Subjects, With Functional Faecal Retention

Constipation Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01670669
• Other study ID #: PRU-USA-24
• Status: Completed
• Phase: Phase 1
• First received: July 31, 2012
• Last updated: August 20, 2012
• Start date: November 1998
• Est. completion date: July 1999

Study information

• Verified date: August 2012
• Source: Movetis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: July 1999
• Est. primary completion date: July 1999
• Gender: Both
• Age group: 4 Years to 12 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Movetis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	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.		No
Primary	Efficacy	Reporting of bowel movement frequency, i.e. average number of bowel movements on a weekly base.		No
Secondary	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.		8 weeks	No