EUCTR2013-002026-22-NL进行中（未招募）不适用
Rectal and oral omeprazole treatment of gastroesophageal reflux in infants with esophageal atresia or congenital diaphragmatic hernia.A pharmacodynamic and pharmacokinetic study - NEOPREMEC
ErasmusMC0 个研究点开始时间: 2013年6月27日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age ± 6 weeks and weight > 3 kg
- •Pathologic GERD, diagnosed by criteria stated in paragraph 2.3 --> pathologic GERD related to esophageal atresia or congenital hernia Diaphragmatica
- •Written Informed consent by both parents
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 20
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Known hypersensitivity to omeprazole
- •Co-medication (or changes to prohibited comedication during the trial): alprazolam, midazolam, triazolam, carbamazepine, clorazepate, ciclosporine, disulfiram, fenytoïne, ferrous components, itraconazole, ketoconazole, voriconazole, methotrexate, tacrolimus, ticlopidine, warfarine
- •Patients with GERD caused by congentital malformations of the CNS
研究者
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