NCT00318968已完成4 期
Development of an Algorithm for Identification of Responders to Short Term Treatment With Esomeprazole (Nexium) in Primary Care
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 1,000
- 试验地点
- 38
- 主要终点
- The primary efficacy variable is the patient's key complaint. A patient whose key complaint has been absent for the last 24 hour of the treatment period (2 weeks +/- 2 days) is defined as a PPI responder.
研究概览
简要总结
The primary purpose of the study is to develop, and test, an algorithm for identification of responders to empirical esomeprazole treatment in general practices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients attending general practice due to symptoms suggestive of acid related disease and, according to normal routine, the GP would prescribe an acid-inhibiting agent
排除标准
- •Alarm symptoms
- •Pregnancy
- •Contraindications to Nexium
结局指标
主要结局
The primary efficacy variable is the patient's key complaint. A patient whose key complaint has been absent for the last 24 hour of the treatment period (2 weeks +/- 2 days) is defined as a PPI responder.
次要结局
- To evaluate the response rate (absence of the key complaint for the last 3 days of the treatment period (2 weeks +/- 2 days)).
研究者
研究点 (38)
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