Prucalopride in Pediatric Subjects With Functional Constipation (FC)

This study has been completed.
Sponsor:
Collaborator:
PRA International
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01330381
First received: April 4, 2011
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Functional Constipation
Drug: prucalopride
Drug: Placebo
Drug: PEG 4000
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • Percent of Responders in the Last Four Weeks of the Double-Blind Treatment Period [ Time Frame: Last 4 weeks of double-blind treatment period ] [ Designated as safety issue: No ]
    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 [ Time Frame: Last 4 weeks of double-blind treatment period ] [ Designated as safety issue: No ]
    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 [ Time Frame: Last 4 weeks of double-blind treatment period ] [ Designated as safety issue: No ]
    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 [ Time Frame: Over the 8 week double blind treatment period ] [ Designated as safety issue: No ]
    Purposefully avoiding defecation.

  • Painful Bowel Movements Score in the Double-Blind Treatment Period [ Time Frame: Over the 8 week double blind treatment period ] [ Designated as safety issue: No ]
    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 [ Time Frame: Over the 8 week double blind treatment period ] [ Designated as safety issue: No ]
    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 [ Time Frame: Over the 8 week double blind treatment period ] [ Designated as safety issue: No ]
    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 [ Time Frame: Over the 8 week double blind treatment period ] [ Designated as safety issue: No ]
    Large diameter stools make defecation more difficult. Small diameter stools are better.

  • Abdominal Pain Score in Double-Blind Treatment Period [ Time Frame: Over the 8 week double blind treatment period ] [ Designated as safety issue: No ]
    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 [ Time Frame: Over the 8 week double blind treatment period ] [ Designated as safety issue: No ]
    Only for subjects after acquisition of toileting skills.

  • Number of Rescue Medications Taken in the Double-Blind Treatment Period [ Time Frame: Over the 8 week double blind treatment period ] [ Designated as safety issue: No ]
  • Time to First SBM in the Double-Blind Treatment Period [ Time Frame: Day 1 onwards ] [ Designated as safety issue: No ]
    After intake of the trial medication on Day 1.

  • Number of SBM Per Week in the Double-Blind Treatment Period [ Time Frame: Over the 8 week double blind treatment period ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Severity of Constipation Over the Past 2 Weeks for the Final On Treatment Assessment in the Double-Blind Treatment Period [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Severity of Constipation Over the Past 2 Weeks for the Final On Treatment Assessment in the Open-Label Treatment Period [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Efficacy of Treatment for Final On Treatment Assessment in Double-Blind Treatment Period [ Time Frame: Over the 8 week double blind treatment period ] [ Designated as safety issue: No ]
  • Efficacy of Treatment for Final On Treatment Assessment in Open-Label Treatment Period [ Time Frame: Over the 16 week open label treatment period ] [ Designated as safety issue: No ]
  • Convenience of Treatment for Final On Treatment Assessment in Open-Label Treatment Period [ Time Frame: Over the 16 week open label treatment period ] [ Designated as safety issue: No ]

Enrollment: 215
Study Start Date: April 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: prucalopride
drug
Drug: prucalopride

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
Placebo Comparator: Placebo Drug: Placebo
Matching oral solution or oral tablets given once daily
Active Comparator: PEG 4000
4-20g administered as an oral solution once daily
Drug: PEG 4000

  Eligibility

Ages Eligible for Study:   6 Months to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01330381

Locations
Netherlands
Academisch Medisch Centrum
Amsterdam, Netherlands, 1105 AZ
Sponsors and Collaborators
Shire
PRA International
  More Information

No publications provided

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01330381     History of Changes
Other Study ID Numbers: SPD555-303, M0001-C303
Study First Received: April 4, 2011
Results First Received: January 7, 2014
Last Updated: January 7, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Italy: Ministry of Health
Hungary:
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014