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Prucalopride in Pediatric Subjects With Functional Constipation (FC)

Primary Purpose

Functional Constipation

Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
prucalopride
Placebo
PEG 4000
Sponsored by
Shire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Constipation

Eligibility Criteria

6 Months - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Academisch Medisch Centrum

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

prucalopride

Placebo

PEG 4000

Arm Description

drug

4-20g administered as an oral solution once daily

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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).
Number of Retentive Posturing or Excessive Volitional Stool Retention in the Double-Blind Treatment Period
Purposefully avoiding defecation.
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.
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.
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.
Large Diameter Stools in the Double-Blind Treatment Period
Large diameter stools make defecation more difficult. Small diameter stools are better.
Abdominal Pain Score in 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.
Frequency of Toilet Training in the Double-Blind Treatment Period
Only for subjects after acquisition of toileting skills.
Number of Rescue Medications Taken in the Double-Blind Treatment Period
Time to First SBM in the Double-Blind Treatment Period
After intake of the trial medication on Day 1.
Number of SBM Per Week in the Double-Blind Treatment Period
Change From Baseline in the Number of SBM Per Week 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
Severity of Constipation Over the Past 2 Weeks for the Final On Treatment Assessment in the Open-Label Treatment Period
Efficacy of Treatment for Final On Treatment Assessment in Double-Blind Treatment Period
Efficacy of Treatment for Final On Treatment Assessment in Open-Label Treatment Period
Convenience of Treatment for Final On Treatment Assessment in Open-Label Treatment Period

Full Information

First Posted
April 4, 2011
Last Updated
May 29, 2021
Sponsor
Shire
Collaborators
PRA Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01330381
Brief Title
Prucalopride in Pediatric Subjects With Functional Constipation
Acronym
FC
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

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
April 28, 2011 (Actual)
Primary Completion Date
March 1, 2013 (Actual)
Study Completion Date
March 1, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire
Collaborators
PRA Health Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Constipation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
215 (Actual)

8. Arms, Groups, and Interventions

Arm Title
prucalopride
Arm Type
Experimental
Arm Description
drug
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
PEG 4000
Arm Type
Active Comparator
Arm Description
4-20g administered as an oral solution once daily
Intervention Type
Drug
Intervention Name(s)
prucalopride
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching oral solution or oral tablets given once daily
Intervention Type
Drug
Intervention Name(s)
PEG 4000
Primary Outcome Measure Information:
Title
Percent of Responders in the Last Four Weeks of the Double-Blind Treatment Period
Description
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 Outcome Measure Information:
Title
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
Description
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
Title
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
Description
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
Title
Number of Retentive Posturing or Excessive Volitional Stool Retention in the Double-Blind Treatment Period
Description
Purposefully avoiding defecation.
Time Frame
Over the 8 week double blind treatment period
Title
Painful Bowel Movements Score in the Double-Blind Treatment Period
Description
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
Title
Stool Consistency Per SBM Score in Children Without Diapers in the Double-Blind Treatment Period
Description
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
Title
Stool Consistency Per SBM Score in Children With Diapers in the Double-Blind Treatment Period
Description
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
Title
Large Diameter Stools in the Double-Blind Treatment Period
Description
Large diameter stools make defecation more difficult. Small diameter stools are better.
Time Frame
Over the 8 week double blind treatment period
Title
Abdominal Pain Score in Double-Blind Treatment Period
Description
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
Title
Frequency of Toilet Training in the Double-Blind Treatment Period
Description
Only for subjects after acquisition of toileting skills.
Time Frame
Over the 8 week double blind treatment period
Title
Number of Rescue Medications Taken in the Double-Blind Treatment Period
Time Frame
Over the 8 week double blind treatment period
Title
Time to First SBM in the Double-Blind Treatment Period
Description
After intake of the trial medication on Day 1.
Time Frame
Day 1 onwards
Title
Number of SBM Per Week in the Double-Blind Treatment Period
Time Frame
Over the 8 week double blind treatment period
Title
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
Title
Severity of Constipation Over the Past 2 Weeks for the Final On Treatment Assessment in the Double-Blind Treatment Period
Time Frame
2 weeks
Title
Severity of Constipation Over the Past 2 Weeks for the Final On Treatment Assessment in the Open-Label Treatment Period
Time Frame
2 weeks
Title
Efficacy of Treatment for Final On Treatment Assessment in Double-Blind Treatment Period
Time Frame
Over the 8 week double blind treatment period
Title
Efficacy of Treatment for Final On Treatment Assessment in Open-Label Treatment Period
Time Frame
Over the 16 week open label treatment period
Title
Convenience of Treatment for Final On Treatment Assessment in Open-Label Treatment Period
Time Frame
Over the 16 week open label treatment period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria: Boys and girls, aged ≥ 6 months and < 18 years. Subjects with a confirmed diagnosis of functional constipation as defined by the Rome III criteria. Main Exclusion Criteria: Children with underlying GI abnormalities and causes for defecation disorders. Constipation is thought to be drug-induced. Subjects suffering from secondary causes of chronic constipation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Academisch Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
25239590
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.
Results Reference
result
PubMed Identifier
27891230
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.
Results Reference
derived

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Prucalopride in Pediatric Subjects With Functional Constipation

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