Prucalopride in Pediatric Subjects With Functional Constipation

Shire215 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

215

Conditions

Functional Constipation

Interventions

prucaloprideDRUG

prucalopride * subjects with weight ≤50kg: 0.04 mg/kg once daily as oral solution of 0.4 mg/ml * subjects with weight \>50 kg: prucalopride 2 mg tablet once daily

PlaceboDRUG

Matching oral solution or oral tablets given once daily

PEG 4000DRUG

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 17 Years

Medical Language ↔ Plain English

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.

Locations (1)

Academisch Medisch Centrum

Amsterdam, Netherlands

Outcomes

Primary Outcomes

Percent of Responders in the Last Four Weeks of the Double-Blind Treatment Period

Responders are defined as subjects with an average spontaneous defecation frequency is ≥3 times per week AND the average number of fecal incontinence episodes per 2 weeks is ≤ 1 episode (only for subjects after acquisition of toileting skills).

Time frame: Last 4 weeks of double-blind treatment period

Secondary Outcomes

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

Spontaneous Bowel Movements defined as a bowel movement that is not preceded within a period of 24 hours by the intake of a laxative agent or by the use of an enema.

Time frame: Last 4 weeks of double-blind treatment period

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

Fecal incontinence is a lack of control over defecation, leading to involuntary loss of bowel contents (only for subjects after acquisition of toileting skills).

Time frame: Last 4 weeks of double-blind treatment period

Number of Retentive Posturing or Excessive Volitional Stool Retention in the Double-Blind Treatment Period

Purposefully avoiding defecation.

Time frame: Over the 8 week double blind treatment period

Painful Bowel Movements Score in the Double-Blind Treatment Period

Pain was rated on a 6-point scale (0=no hurt, 1=hurts little bit, 2=hurts little more, 3=hurts even more, 4=hurts whole lot, 5=hurts worst) in subjects of 3 years and older. Lower scores represent less pain.

Time frame: Over the 8 week double blind treatment period

Data from ClinicalTrials.gov

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Stool Consistency Per SBM Score in Children Without Diapers in the Double-Blind Treatment Period

Measured using the 7-point Bristol scale where 1-2 indicate constipation, 3-4 are ideal stools, and 5-7 tending toward diarrhea.

Time frame: Over the 8 week double blind treatment period

Stool Consistency Per SBM Score in Children With Diapers in the Double-Blind Treatment Period

Measured on a 4-point scale where 1 is constipation, 2-3 is ideal, and 4 is diarrhea.

Time frame: Over the 8 week double blind treatment period

Large Diameter Stools in the Double-Blind Treatment Period

Large diameter stools make defecation more difficult. Small diameter stools are better.

Time frame: Over the 8 week double blind treatment period

Abdominal Pain Score in Double-Blind Treatment Period

Time frame: Over the 8 week double blind treatment period

Frequency of Toilet Training in the Double-Blind Treatment Period

Only for subjects after acquisition of toileting skills.

Time frame: Over the 8 week double blind treatment period

Number of Rescue Medications Taken in the Double-Blind Treatment Period

Time frame: Over the 8 week double blind treatment period

Time to First SBM in the Double-Blind Treatment Period

After intake of the trial medication on Day 1.

Time frame: Day 1 onwards

Number of SBM Per Week in the Double-Blind Treatment Period

Time frame: Over the 8 week double blind treatment period

Change From Baseline in the Number of SBM Per Week Over the 8 Week Double Blind Treatment Period

Time frame: Baseline and over the 8 week double blind treatment period

Severity of Constipation Over the Past 2 Weeks for the Final On Treatment Assessment in the Double-Blind Treatment Period

Time frame: 2 weeks

Severity of Constipation Over the Past 2 Weeks for the Final On Treatment Assessment in the Open-Label Treatment Period

Time frame: 2 weeks

Efficacy of Treatment for Final On Treatment Assessment in Double-Blind Treatment Period

Time frame: Over the 8 week double blind treatment period

Efficacy of Treatment for Final On Treatment Assessment in Open-Label Treatment Period

Time frame: Over the 16 week open label treatment period

Convenience of Treatment for Final On Treatment Assessment in Open-Label Treatment Period

Time frame: Over the 16 week open label treatment period