R108512 SOLUTION IN PEDIATRIC SUBJECTS W/ FUNCTIONAL FECAL RETENTION

在儿科人群中，便秘是所有儿科门诊就诊中约3%的主诉；多达25%转介给儿科胃肠科医生的是患有便秘的儿童。这些儿童中的大多数都有一种形式的功能性便秘，称为FFR或功能性粪便潴留。本试验的主要目的是表征单次口服0.03 mg/kg普芦哌利在4岁以上至12岁以下FFR患儿中的药代动力学。这个剂量相当于成人的剂量。普鲁卡必利15 - 2.0毫克。次要目的是评估儿童FFR患者口服单剂量0.03 mg/kg普鲁卡必利溶液的安全性和耐受性（不良反应）。本试验不评估疗效。对GCRC进行了药代动力学研究。

In the pediatric population, constipation is the chief complaint in about 3% of all pediatric outpatient visits; as many as 25% of referrals to pediatric gastroenterologists are for children with constipation. The majority of these children have a form of functional constipation, referred to as FFR or functional fecal retention. The primary objective of this trial is to characterize the pharmacokinetics of a single oral dose of 0.03 mg/kg prucalopride in pediatric subjects aged greater than 4 to less than 12 years with FFR. This dose corresponds to an adult dose of .15 - 2.0 mg of prucalopride. The secondary objective is to evaluate the safety and the tolerability (adverse experiences) of a single oral dose of prucalopride solution, 0.03 mg/kg, given to pediatric subjects with FFR. No efficacy will be evaluated in this trial. Pharmacokinetic studies were done on the GCRC.