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

Tracking Information
First Received Date ^ICMJE	April 4, 2011
Last Updated Date	April 25, 2013
Start Date ^ICMJE	April 2011
Primary Completion Date	March 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 5, 2011)	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).
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01330381 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 5, 2011)	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.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Prucalopride in Pediatric Subjects With Functional Constipation
Official Title ^ICMJE	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
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Functional Constipation
Intervention ^ICMJE	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 Drug: prucalopride prucalopride open label once daily or active control (PEG 4000 (Forlax® junior < 8 years and Forlax® ≥ 8 years)
Study Arm (s)	Placebo Comparator: prucalopride drug Intervention: Drug: prucalopride Active Comparator: open label comparator drug Intervention: Drug: prucalopride
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	210
Completion Date	March 2013
Primary Completion Date	March 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	6 Months to 17 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Netherlands

Administrative Information
NCT Number ^ICMJE	NCT01330381
Other Study ID Numbers ^ICMJE	M0001-C303
Has Data Monitoring Committee	Yes
Responsible Party	Movetis
Study Sponsor ^ICMJE	Movetis
Collaborators ^ICMJE	PRA International
Investigators ^ICMJE	Not Provided
Information Provided By	Movetis
Verification Date	April 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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