R108512 SOLUTION IN PEDIATRIC SUBJECTS W/ FUNCTIONAL FECAL RETENTION

R108512 具有功能性粪便保留功能的儿科解决方案

• 批准号: 6264435
• 负责人: JEFFREY L. BLUMER
• 金额: $ 1.92万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6264435
• 关键词: child (0-11); clinical research; constipation; drug adverse effect; drug screening /evaluation; gastrointestinal agents; gastrointestinal disorder chemotherapy; human subject; pediatric pharmacology; pharmacokinetics

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 less than/greater than 4 to less than/greater 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.

在儿科人群中，便秘是约3%的儿科门诊就诊的主要主诉;多达25%的儿科胃肠病学家转诊是便秘儿童。 这些儿童中的大多数患有功能性便秘，称为FFR或功能性粪便潴留。本试验的主要目的是描述在小于/大于4岁至小于/大于12岁的具有血流储备分数的儿科受试者中单次口服0.03 mg/kg普卢卡必利的药代动力学特征。 该剂量相当于成人剂量0.15 - 2.0 mg普卢卡必利。 次要目的是评价对FFR儿科受试者单次口服普卢卡必利溶液（0.03 mg/kg）的安全性和耐受性（不良反应）。 本试验不评价疗效。