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: June 10, 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, 2010-022402-40
Study First Received: April 4, 2011
Results First Received: January 7, 2014
Last Updated: June 10, 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 September 18, 2014