Pharmacokinetics of Enteral Omeprazole Suspension in Patients With Cerebral Palsy and Mental Retardation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Pharmacokinetics (at the end of the treatment period of 14 days)
研究概览
简要总结
Gastroesophageal reflux disease and reflux-esophagitis are a major chronic problem in most children with cerebral palsy and mental retardation. Oral administration of enteric-coated formulations of the acid-labile proton pump inhibitor omeprazole is often problematic in these patients who may be suffering from swallowing disorders. A suspension of omeprazole in a sodium bicarbonate solution is often used for administration via the gastrostomy tube. This trial aims to compare the pharmacokinetics of omeprazole administered through the gastrostomy tube as a suspension in pediatric patients with cerebral palsy and mental retardation versus the pharmacokinetics of omeprazole administered as a multi-unit-pellet system (MUPS®). The crossover study will consist of 2 consecutive treatment periods of 14 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children > 15 kg
- •Cerebral palsy and mental retardation with swallowing disorders
- •Presence of gastrostomy tube
- •GERD and/or reflux-esophagitis treated with omeprazole at the same dose since at least 2 weeks
- •Informed consent
排除标准
- •Treatment with ciclosporine, tacrolimus, mycofenolate
- •Treatment with anticoagulants
- •Infection
- •Recent start of treatment with known inhibitors of the omeprazole-metabolism
- •Moderate to severe hepatic impairment (SGPT and/or AST > 3 times upper limit)
结局指标
主要结局
Pharmacokinetics (at the end of the treatment period of 14 days)
次要结局
- Gastric pH (at the end of the treatment period of 14 days)