Constipation
Conditions
Brief 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.
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
DRUGprucalopride
0.01 mg/kg/day to 0.03 mg/kg/day prucalopride (R108512) oral solution
Sponsors
Movetis
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Age
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Efficacy | — | Reporting of bowel movement frequency, i.e. average number of bowel movements on a weekly base. |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Outcome results
None listed