NCT03562026已完成不适用
Specific Clinical Experience Investigation of Nexium in Paediatric Patients
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
- 240
- 试验地点
- 1
- 主要终点
- frequency of adverse drug reactions (ADRs)
研究概览
简要总结
To capture safety and efficacy when Nexium are administered to pediatric patients in clinical practice after launch
详细描述
The objective of this investigation is to capture the followings when Nexium capsules or Nexium granules for suspension (single-dose package) are administered to pediatric patients in clinical practice after launch.
- Development of adverse reactions which are unexpected from Precaution for Use
- Development of adverse reactions
- Efficacy
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 1(inclusive) to 15 (exclusive) years
- •Patients who have been prescribed Nexium for the first time for "gastric ulcer", "duodenal ulcer", "anastomotic ulcer", "reflux oesophagitis", "non-erosive reflux disease", or "Zollinger-Ellison syndrome", .
排除标准
- •Patients with a history of hypersensitivity to components contained in this product.
- •Patients during treatment with Atazanavir Sulfate and Rilpivirine hydrochloride.
结局指标
主要结局
frequency of adverse drug reactions (ADRs)
时间窗: up to 8 weeks
Development of ADRs by unexpected from "Precautions for Use" of Nexium JPI, by SOC, by patient demography and by treatment
rate of improvement/worsening of symptoms
时间窗: up to 8 weeks
Rage of improvement/worsening of symptoms and cure rate on endoscopy
次要结局
未报告次要终点
研究者
研究点 (1)
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