Prucalopride in paediatric patients with constipation

• Research type

  Research Study

• Full 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 over 6 months to under 18 years, followed by a 16-week open-label comparator (PEG) controlled part, to document safety and tolerability up to 24 weeks

• IRAS ID

  72889

• Contact name

  Benjamin Odeka

• Sponsor organisation

  Shire-Movetis NV

• Eudract number

  2010-022402-40

• Research summary

  STUDY TO EVALUATE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PRUCALOPRIDE IN PAEDIATRIC SUBJECTS WITH FUNCTIONAL CONSTIPATION, AGED =6 MONTHS TO <18 YEARS Constipation is a common paediatric problem. Approximately 3% of general paediatric outpatient visits and 25% of paediatric gastroenterology consultations are related to a perceived defaecation disorder. Yet, as in adults, in only a small proportion of children (approximately 10%) an organic cause for constipation can be defined (Naspghan 2006).Prucalopride is a new drug that stimulates gastrointestinal movement. It received a marketing authorisation from the European Commission in 2009 for the treatment of chronic constipation in women in whom laxatives fail to provide adequate relief.Results obtained from 2700 subjects, including children, during phase I to III studies confirmed the safety and efficacy of prucalopride in gastrointestinal disorders such as chronic constipation. The design of this study is in line with the paediatric investigation plan of prucalopride as agreed with the Paediatric Committee of the European Medicines Agency.At least 210 boys and girls aged ?¾6 months to <18 years will take part in this study. Total duration of the study is 25 to 26.5 weeks. The study consists of 3 phases: (1)Run-in period of 1 to 2.5 weeks,(2) treatment period of 24 weeks - 8 weeks of double-blind, placebo-controlled phase, followed by 16 weeks of open-label, active controlled treatment with prucalopride vs. PEG. Participants will be required to visit the study centre up to 8 times throughout the study duration.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  11/NW/0177

• Date of REC Opinion

  16 May 2011

• REC opinion

  Further Information Favourable Opinion