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: 6305375
• 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: 1999
• 资助国家: 美国
• 起止时间: 1999-12-01 至 2000-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6305375
• 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 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.

在小儿人群中，便秘是所有小儿门诊就诊的主要投诉。小儿胃肠病学家的转诊中多达25％是针对便秘儿童的。 这些儿童中的大多数具有一种功能性便秘形式，称为FFR或功能性粪便保留。该试验的主要目的是表征单一口服剂量为0.03 mg/kg prucalopride的药代动力学在大于4至12岁的小儿患者中的药代动力学。 这种剂量对应于成年剂量为.15-2.0 mg的prucalopride。 次要目标是评估单个口服剂量剂量溶液的安全性和耐受性（不利经历），为0.03 mg/kg，用FFR给予儿科受试者。 在此试验中不会评估疗效。 在GCRC上进行了药代动力学研究。