Single Dose Pharmacokinetics of Prucalopride in Paediatric Subjects, With Functional Faecal Retention

NCT01674166 | Completed Phase 1

• 1 other identifier: PRU-USA-12
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is characterize the pharmacokinetics of a single oral dose of 0.03 mg/kg prucalopride in paediatric subjects aged \>= 4 to \<= 12 years with functional faecal retention. Hypothesis: Pharmacokinetic profile of prucalopride in paediatric subjects is expected to resemble the adult pharmacokinetic profile

Conditions

Constipation

Outcome Measures

Primary Outcomes (1)

• To characterize the pharmacokinetics of a single oral dose of 0.03 mg/kg prucalopride in paediatric subjects aged >= 4 to <= 12 years with functional faecal retention.

Secondary Outcomes (1)

• Secondary efficacy variables: safety and tolerability of a single dose of prucalopride 0.03 mg/kg given to paediatric subjects with FFR.

Study Arms (1)

prucalopride

EXPERIMENTAL

single dose 0.03 mg/kg prucalopride open label

Drug: prucalopride

Interventions

prucalopride DRUG

single dose 0.03 mg/kg prucalopride open label

prucalopride

Eligibility Criteria

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

You may qualify if:

• Subjects with a confirmed diagnosis of FFR, defined as a minimum 2-month history of faecal impaction, plus at least one of the following:
• \< 3 bowel movements per week at the toilet;
• A history of soiling;
• Male and female subjects ≥ 4 to ≤ 12 years of age, with a Tanner stage 1 of 2 or less;
• Weight-height proportionality for age within the 5th and 95th percentile;
• Written informed consent, signed by the subject's legal guardian and by the investigator, and;
• Subject assent documented in the form of a note-to-file in the subject's source documentation.

You may not qualify if:

• Requirement for any medication during the period of the trial;
• Evidence by examination or laboratory tests of abnormal growth;
• An abnormal neurologic examination;
• Cystic fibrosis;
• History of, or current anorectal malformations;
• Diagnosed chromosomal abnormalities (e.g., Down's Syndrome);
• Disease state or surgery known to significantly affect the gastrointestinal absorption of drugs, or the assessment of the trial drug's effect;
• Any history, clinical and/or biochemical evidence of clinically significant renal or liver disease or cirrhosis;
• Clinically significant anaemia;
• Use of any investigational drug within the 4-week period prior to administration of trial medication.

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: August 24, 2012
• First Posted: August 28, 2012
• Study Start: November 1, 1998
• Primary Completion: May 1, 1999
• Study Completion: May 1, 1999
• Last Updated: August 28, 2012

Record last verified: 2012-06