Clinical trial NCT01330381: Prucalopride in Pediatric Subjects With Functional Constipation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Functional Constipation
Lead sponsor: Takeda
Sponsor class: INDUSTRY
Collaborators: name: PRA Health Sciences
First posted: 2011-04-06
Enrollment: 215
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Main Inclusion Criteria:

1. Boys and girls, aged ≥ 6 months and \< 18 years.
2. Subjects with a confirmed diagnosis of functional constipation as defined by the Rome III criteria.

Main Exclusion Criteria:

1. Children with underlying GI abnormalities and causes for defecation disorders.
2. Constipation is thought to be drug-induced.
3. Subjects suffering from secondary causes of chronic constipation.

Primary outcomes:
measure: Percent of Responders in the Last Four Weeks of the Double-Blind Treatment Period
timeFrame: Last 4 weeks of double-blind treatment period
Secondary outcomes:
measure: Percent of Subjects With Bowel Frequency of 3 or More Spontaneous Bowel Movements (SBM) Per Week in the Last Four Weeks of the Double-Blind Treatment Period
timeFrame: Last 4 weeks of double-blind treatment period
measure: Percent of Subjects With Fecal Incontinence Episodes of 1 or Less Per 2 Weeks in the Last Four Weeks of the Double-Blind Treatment Period
timeFrame: Last 4 weeks of double-blind treatment period
measure: Number of Retentive Posturing or Excessive Volitional Stool Retention in the Double-Blind Treatment Period
timeFrame: Over the 8 week double blind treatment period
measure: Painful Bowel Movements Score in the Double-Blind Treatment Period
timeFrame: Over the 8 week double blind treatment period
measure: Stool Consistency Per SBM Score in Children Without Diapers in the Double-Blind Treatment Period
timeFrame: Over the 8 week double blind treatment period
measure: Stool Consistency Per SBM Score in Children With Diapers in the Double-Blind Treatment Period
timeFrame: Over the 8 week double blind treatment period
measure: Large Diameter Stools in the Double-Blind Treatment Period
timeFrame: Over the 8 week double blind treatment period
measure: Abdominal Pain Score in Double-Blind Treatment Period
timeFrame: Over the 8 week double blind treatment period
measure: Frequency of Toilet Training in the Double-Blind Treatment Period
timeFrame: Over the 8 week double blind treatment period
measure: Number of Rescue Medications Taken in the Double-Blind Treatment Period
timeFrame: Over the 8 week double blind treatment period
measure: Time to First SBM in the Double-Blind Treatment Period
timeFrame: Day 1 onwards
measure: Number of SBM Per Week in the Double-Blind Treatment Period
timeFrame: Over the 8 week double blind treatment period
measure: Change From Baseline in the Number of SBM Per Week Over the 8 Week Double Blind Treatment Period
timeFrame: Baseline and over the 8 week double blind treatment period
measure: Severity of Constipation Over the Past 2 Weeks for the Final On Treatment Assessment in the Double-Blind Treatment Period
timeFrame: 2 weeks
measure: Severity of Constipation Over the Past 2 Weeks for the Final On Treatment Assessment in the Open-Label Treatment Period
timeFrame: 2 weeks
measure: Efficacy of Treatment for Final On Treatment Assessment in Double-Blind Treatment Period
timeFrame: Over the 8 week double blind treatment period
measure: Efficacy of Treatment for Final On Treatment Assessment in Open-Label Treatment Period
timeFrame: Over the 16 week open label treatment period
measure: Convenience of Treatment for Final On Treatment Assessment in Open-Label Treatment Period
timeFrame: Over the 16 week open label treatment period
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Mugie SM, Korczowski B, Bodi P, Green A, Kerstens R, Ausma J, Ruth M, Levine A, Benninga MA. Prucalopride is no more effective than placebo for children with functional constipation. Gastroenterology. 2014 Dec;147(6):1285-95.e1. doi: 10.1053/j.gastro.2014.09.005. Epub 2014 Sep 16.
citation: van Schaick E, Benninga MA, Levine A, Magnusson M, Troy S. Development of a population pharmacokinetic model of prucalopride in children with functional constipation. Pharmacol Res Perspect. 2016 Jun 1;4(4):e00236. doi: 10.1002/prp2.236. eCollection 2016 Aug.