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Prucalopride in Pediatric Subjects With Functional Constipation (FC)

This study has been completed.
Sponsor:
Collaborator:
PRA International
Information provided by (Responsible Party):
Movetis
ClinicalTrials.gov Identifier:
NCT01330381
First received: April 4, 2011
Last updated: April 25, 2013
Last verified: April 2013
History of Changes
  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
 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:

MedlinePlus related topics: Constipation
U.S. FDA Resources

Further study details as provided by Movetis:

Primary Outcome Measures:
  • Efficacy [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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. Efficacy is evaluated by the proportion of responders in the prucalopride vs. placebo arm. A subject is defined as a responder when the average spontaneous defecation frequency is ≥3 times/week AND the average number of faecal incontinence episodes per 2 weeks is ≤ 1 episode (as calculated over week 5 to 8 of the double-blind treatment phase).


Secondary Outcome Measures:
  • individual symptoms defined by the Rome III criteria [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Investigation of the individual symptoms defined by the Rome III criteria: bowel frequency, faecal incontinence, retentive posturing or excessive volitional stool retention, defecation pain, stool consistency, occurrence of large diameter stools. In addition use of rescue medication, abdominal pain and toilet training* (*only for children after acquisition of toileting skills (as standard of care))

  • Pharmacokinetics [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Pharmacokinetics: sparse blood sampling at single dose and steady state to enable population pharmacokinetic modelling.

  • Safety and tolerability [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

    Safety and tolerability: evaluation of prucalopride treatment:

    Blood samples for biochemistry/haematology and urine samples for urinalysis will be taken at visit 1, visit 6 and visit 8.

    All non-related and trial medication related AEs, will be recorded from signing the ICF onwards till the last trial-related visit.



Enrollment: 210
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
Placebo Comparator: 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
Active Comparator: open label comparator
drug
 Drug: prucalopride
prucalopride open label once daily or active control (PEG 4000 (Forlax® junior < 8 years and Forlax® ≥ 8 years)

  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
Movetis
PRA International
  More Information

No publications provided

Responsible Party: Movetis
ClinicalTrials.gov Identifier: NCT01330381     History of Changes
Other Study ID Numbers: M0001-C303
Study First Received: April 4, 2011
Last Updated: April 25, 2013
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 May 21, 2013