NCT01330381

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
215

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 6, 2011

Completed
22 days until next milestone

Study Start

First participant enrolled

April 28, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
12 months until next milestone

Results Posted

Study results publicly available

February 26, 2014

Completed
Last Updated

June 10, 2021

Status Verified

May 1, 2021

Enrollment Period

1.8 years

First QC Date

April 4, 2011

Results QC Date

January 7, 2014

Last Update Submit

May 29, 2021

Conditions

Functional Constipation

Outcome Measures

Primary Outcomes (1)

  • 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).

    Last 4 weeks of double-blind treatment period

Secondary Outcomes (18)

  • 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

  • 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

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

    Over the 8 week double blind treatment period

  • Painful Bowel Movements Score in the Double-Blind Treatment Period

    Over the 8 week double blind treatment period

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

    Over the 8 week double blind treatment period

  • +13 more secondary outcomes

Study Arms (3)

prucalopride

EXPERIMENTAL

drug

Drug: prucalopride

Placebo

PLACEBO COMPARATOR
Drug: Placebo

PEG 4000

ACTIVE COMPARATOR

4-20g administered as an oral solution once daily

Drug: PEG 4000

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

prucalopride
PlaceboDRUG

Matching oral solution or oral tablets given once daily

Placebo
PEG 4000DRUG
PEG 4000

Eligibility Criteria

Age6 Months - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academisch Medisch Centrum

Amsterdam, 1105 AZ, Netherlands

Location

Related Publications (2)

  • 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.

    PMID: 25239590RESULT

  • 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.

    PMID: 27891230DERIVED

MeSH Terms

Interventions

prucalopridePolyethylene Glycols

Intervention Hierarchy (Ancestors)

Ethylene GlycolsGlycolsAlcoholsOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Results Point of Contact

Title
Study Director
Organization
Shire
ClinicalTransparency@shire.com
+1 866 842 5335

Study Officials

  • Study Director

    Takeda

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2011

First Posted

April 6, 2011

Study Start

April 28, 2011

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

June 10, 2021

Results First Posted

February 26, 2014

Record last verified: 2021-05

Locations

NL(1)