NL-OMON38919已完成2 期
Rectal and oral omeprazole treatment of gastroesophageal reflux in infants with esophageal atresia or congenital diaphragmatic hernia: A pharmacodynamic and pharmacokinetic study - Neopremec
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 11（—）
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
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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