Prucalopride in Paediatric Subjects, With Functional Faecal Retention

NCT01670669 | Completed Phase 1

• 1 other identifier: PRU-USA-24
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is characterize the efficacy, safety, tolerability, and steady-state plasma levels after once-daily oral dosing of prucalopride (R108512) as a solution, 0.01 mg/kg to 0.03 mg/kg, given to paediatric subjects with functional faecal retention (FFR) for 8 weeks. Hypothesis: Pharmacokinetic profile of prucalopride in paediatric subjects is expected to resemble the adult pharmacokinetic profile. Safety and tolerability profile are expected to resemble the adult profile.

Conditions

Constipation

Outcome Measures

Primary Outcomes (2)

• Adverse events

  Adverse events (AEs) to be recorded by spontanous reporting or after non-leading questioning i.e. reporting of all AEs and its duration during the course of the trial. In addition at bi-weekly visits laboratory assessments, vitals signs, ECGs and physical examinations, reported as mean values and clinical significant abnormalities to be tabulated. Efficacy: reporting of bowel movements and its characteristics in a diary.

• Efficacy

  Reporting of bowel movement frequency, i.e. average number of bowel movements on a weekly base.

Secondary Outcomes (1)

• Secondary efficacy variables: steady-state plasma levels after once-daily oral dosing of prucalopride (R108512) as a solution, 0.01 mg/kg to 0.03 mg/kg, given to paediatric subjects with functional faecal retention (FFR) for 8 weeks.

  8 weeks

Study Arms (1)

prucalopride

ACTIVE COMPARATOR

0.01 mg/kg/day to 0.03 mg/kg/day prucalopride (R108512) oral solution

Drug: prucalopride

Interventions

prucalopride DRUG

0.01 mg/kg/day to 0.03 mg/kg/day prucalopride (R108512) oral solution

prucalopride

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Age Groups: Child (0-17)

You may qualify if:

• Subject completed the PRU-USA-12 pharmacokinetic trial
• Subject bowels had been "cleaned-out" (ie, any faecal impactions removed)
• Written informed consent, signed by the subject's legal guardian and by the investigator
• Subject assent documented in the form of a note-to-file in the subject's source documentation

Sponsors & Collaborators

• Movetis: lead

Related Publications (1)

• Winter HS, Di Lorenzo C, Benninga MA, Gilger MA, Kearns GL, Hyman PE, Vandeplassche L, Ausma J, Hoppenbrouwers M. Oral prucalopride in children with functional constipation. J Pediatr Gastroenterol Nutr. 2013 Aug;57(2):197-203. doi: 10.1097/MPG.0b013e318292f9ea.

  PMID: 23535761 DERIVED

MeSH Terms

Conditions

Constipation

Interventions

prucalopride

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Harald Winter, M.D.

  Massachusetts General Hospital for Children, Boston, Massachusetts, USA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2012
• First Posted: August 22, 2012
• Study Start: November 1, 1998
• Primary Completion: July 1, 1999
• Study Completion: July 1, 1999
• Last Updated: August 22, 2012

Record last verified: 2012-08