NCT01338363已完成不适用
Drug Utilization and Safety Events Among Children Using Esomeprazole, Other Proton Pump Inhibitors or H2-receptor Antagonists
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 23,470
- 试验地点
- 1
- 主要终点
- Drug utilization: Description of patient characteristics and drug usage
研究概览
简要总结
The purpose of this study is
- To describe patient characteristics and drug usage among children that are prescribed esomeprazole for the first time and to compare them with patients who are prescribed other proton pump inhibitors (PPIs) or H2-receptor antagonists for the first time.
- To ascertain all incident hospitalized cases of angioneurotic oedema, pneumonia, gastroenteritis, failure to thrive, convulsions/seizures, acute interstitial nephritis and thrombocytopenia among new users in the three cohorts of esomeprazole, other PPIs and H2-receptor antagonists.
详细描述
Time Perspective: Other = Retrospective analysis of prospectively collected data Number of Anticipated Subjects: All subjects dispensed esomeprazole, other PPIs or H2-receptor antagonists for the first time during the study period
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 0-18 years
- •Newly dispensed esomeprazole, other proton pump inhibitors or H2-receptor antagonists
排除标准
- •Children with less than one year of history in PHARMO RLS before study cohort entry (if a child is <1 year at cohort entry, history from birth is required)
- •Children using more than 1 acid suppressing drug concomitantly at cohort entry
结局指标
主要结局
Drug utilization: Description of patient characteristics and drug usage
时间窗: Study period 3 years
Follow-up of safety outcomes: First occurrence of hospitalized angioneurotic oedema, pneumonia, gastroenteritis, failure to thrive, convulsions/seizures, acute interstitial nephritis and thrombocytopenia
时间窗: 18 months
次要结局
未报告次要终点
研究者
研究点 (1)
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