NCT01744301已完成不适用
A Cohort Study With a Nested Case Control Analysis on the Association Between Acid-suppressing Drugs and Seizures Using THIN Database in the UK
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 8,605
- 试验地点
- 1
- 主要终点
- Incidence of seizure in the general population and stratified by epilepsy status.
研究概览
简要总结
The purpose of this study is
- to estimate the incidence of seizure in the general population and stratified by epilepsy status
- To estimate the relative risk of seizure associated with use of proton pump inhibitors and histamine 2 receptor antagonist and stratified by epilepsy status
详细描述
A cohort study with a nested case control analysis on the association between acid-suppressing drugs and seizures using THIN database in the UK
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary care physician for at least 2 years.
- •Computerized prescription history of at least 1 year.
- •Patients will have to be free of acid-suppressing drugs (PPI or H2RA) for at least one year.
- •No diagnosis of cancer.
- •No alcohol abuse or alcohol-related disease- No drug abuse.
排除标准
- •Patients with at least 1 prescription of PPI or H2RA in the year prior to start date.
- •Cancer before start date.
- •Alcohol abuse or alcohol-related disease before start date.
- •Drug abuse before start date.
研究组 & 干预措施
All patients newly prescribed PPI
All patients newly prescribed PPI
干预措施: Risk of seizure (Drug)
All patients newly prescribed H2RA
All patients newly prescribed H2RA
干预措施: Risk of seizure (Drug)
结局指标
主要结局
Incidence of seizure in the general population and stratified by epilepsy status.
时间窗: Participants will be followed for the duration of the study period 1 January 2005-31 December 2011, an expected average of 3 years.
Follow-up of safety outcomes: First recorded entry of seizure.
时间窗: Participants will be followed for the duration of the study period 1 January 2005-31 December 2011, an expected average of 3 years.
次要结局
未报告次要终点
研究者
研究点 (1)
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