Prucalopride in Pediatric Subjects With Functional Constipation

Phase 3

Completed

• Conditions: Functional Constipation
• Interventions: Drug: PEG 4000; Drug: Placebo; Drug: prucalopride

• Registration Number: NCT01330381
• Lead Sponsor: Shire

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-04-04
• Study First Submitted QC: 2011-04-05
• Study First Posted: 2011-04-06
• Study Start: 2011-04-28
• Primary Completion: 2013-03-01
• Study Completion: 2013-03-01
• Results First Submitted: 2014-01-07
• Results First Submitted QC: 2014-01-07
• Results First Posted: 2014-02-26
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-29
• Last Update Posted: 2021-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 215

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEG 4000	PEG 4000	4-20g administered as an oral solution once daily
Placebo	Placebo	-
prucalopride	prucalopride	drug

Primary Outcome Measures

Name	Time	Method
Percent of Responders in the Last Four Weeks of the Double-Blind Treatment Period	Last 4 weeks of 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).

Secondary Outcome Measures

Name	Time	Method
Number of Retentive Posturing or Excessive Volitional Stool Retention in the Double-Blind Treatment Period	Over the 8 week double blind treatment period	Purposefully avoiding defecation.
Time to First SBM in the Double-Blind Treatment Period	Day 1 onwards	After intake of the trial medication on Day 1.
Severity of Constipation Over the Past 2 Weeks for the Final On Treatment Assessment in the Double-Blind Treatment Period	2 weeks
Severity of Constipation Over the Past 2 Weeks for the Final On Treatment Assessment in the Open-Label Treatment Period	2 weeks
Painful Bowel Movements Score in the Double-Blind Treatment Period	Over the 8 week 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.
Stool Consistency Per SBM Score in Children Without Diapers in the Double-Blind Treatment Period	Over the 8 week 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.
Stool Consistency Per SBM Score in Children With Diapers in the Double-Blind Treatment Period	Over the 8 week double blind treatment period	Measured on a 4-point scale where 1 is constipation, 2-3 is ideal, and 4 is diarrhea.
Large Diameter Stools in the Double-Blind Treatment Period	Over the 8 week double blind treatment period	Large diameter stools make defecation more difficult. Small diameter stools are better.
Frequency of Toilet Training in the Double-Blind Treatment Period	Over the 8 week double blind treatment period	Only for subjects after acquisition of toileting skills.
Number of Rescue Medications Taken in the Double-Blind Treatment Period	Over the 8 week double blind treatment period
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	Last 4 weeks of 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.
Abdominal Pain Score in Double-Blind Treatment Period	Over the 8 week 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.
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	Last 4 weeks of 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).
Efficacy of Treatment for Final On Treatment Assessment in Double-Blind Treatment Period	Over the 8 week double blind treatment period
Number of SBM Per Week in the Double-Blind Treatment Period	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	Baseline and over the 8 week double blind treatment period
Efficacy of Treatment for Final On Treatment Assessment in Open-Label Treatment Period	Over the 16 week open label treatment period
Convenience of Treatment for Final On Treatment Assessment in Open-Label Treatment Period	Over the 16 week open label treatment period

Trial Locations

Locations (1)

Academisch Medisch Centrum; 🇳🇱 Amsterdam, Netherlands