NCT00318084已完成4 期
The Proton Pump Inhibitor Test in Reflux Disease: a Study Using Nexium in General Practice Patients
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
- 100
- 试验地点
- 1
- 主要终点
- Diagnostic test characteristics and the positive and negative predictive value of a 2-week Nexium-based PPI test using symptom analysis of 24-hour esophageal pH monitoring as gold standard.
研究概览
简要总结
The purpose of this study is to determine the diagnostic value of two week treatment with Nexium as a confirmatory test for patients with suspected reflux disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Age ≥ 18 years
- •Symptoms suggestive for gastric acid reflux disease during 2 or more days per week
排除标准
- •Treatment with prokinetic or acid secretion inhibitors within 4 weeks prior to inclusion
- •Treatment with a PPI for more than 30 days within the last 3 months prior to inclusion
- •History of proven peptic ulcer disease, unless successfully treated with Helicobacter pylori eradication longer than 1 month before inclusion
结局指标
主要结局
Diagnostic test characteristics and the positive and negative predictive value of a 2-week Nexium-based PPI test using symptom analysis of 24-hour esophageal pH monitoring as gold standard.
次要结局
- To assess the optimal duration of a Nexium-based PPI test, and the predictive value of different symptoms for presence of reflux-related symptoms.
- Obtain information on patient satisfaction, the course of reflux symptoms, the consumption of acid suppressing drugs, the disease-related quality of life at a follow up periods of 3 months in patients with a positive and negative PPI test.
研究者
研究点 (1)
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