Prucalopride in Pediatric Subjects With Functional Constipation (FC)
To evaluate the efficacy of prucalopride compared to placebo for the treatment of functional constipation in a paediatric population, aged ≥ 6 months to < 18 years. A 16-week open-label comparator (PEG) controlled part will follow, to document safety and tolerability up to 24 weeks.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Trial Consisting of an 8-week Double-blind Placebo-controlled Part to Evaluate Efficacy, Safety, Tolerability and Pharmacokinetics of Prucalopride in Paediatric Subjects With Functional Constipation, Aged ≥6 Months to <18 Years, Followed by a 16-week Open-label Comparator (PEG) Controlled Part, to Document Safety and Tolerability up to 24 Weeks|
- Efficacy [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]To evaluate the efficacy of prucalopride compared to placebo for the treatment of functional constipation in a paediatric population, aged ≥6 months to <18 years. Efficacy is evaluated by the proportion of responders in the prucalopride vs. placebo arm. A subject is defined as a responder when the average spontaneous defecation frequency is ≥3 times/week AND the average number of faecal incontinence episodes per 2 weeks is ≤ 1 episode (as calculated over week 5 to 8 of the double-blind treatment phase).
- individual symptoms defined by the Rome III criteria [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]Investigation of the individual symptoms defined by the Rome III criteria: bowel frequency, faecal incontinence, retentive posturing or excessive volitional stool retention, defecation pain, stool consistency, occurrence of large diameter stools. In addition use of rescue medication, abdominal pain and toilet training* (*only for children after acquisition of toileting skills (as standard of care))
- Pharmacokinetics [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Pharmacokinetics: sparse blood sampling at single dose and steady state to enable population pharmacokinetic modelling.
- Safety and tolerability [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Safety and tolerability: evaluation of prucalopride treatment:
Blood samples for biochemistry/haematology and urine samples for urinalysis will be taken at visit 1, visit 6 and visit 8.
All non-related and trial medication related AEs, will be recorded from signing the ICF onwards till the last trial-related visit.
|Study Start Date:||April 2011|
|Study Completion Date:||March 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Placebo Comparator: prucalopride
Active Comparator: open label comparator
prucalopride open label once daily or active control (PEG 4000 (Forlax® junior < 8 years and Forlax® ≥ 8 years)