NCT00901004已完成不适用
Non-interventional, Cross-sectional, Multi-center Study to Establish The Clinical Significance of Minimal Change in Reflux Esophagitis Based on the Gastroesophageal Reflux Disease Questionnaire (GerdQ)
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
- 1,550
- 试验地点
- 1
- 主要终点
- To investigate significant minimal change endoscopic finding of reflux esophagitis diagnosis
研究概览
简要总结
The purpose of this study is to define the endoscopic findings of minimal change that is significant to clinical significant reflux esophagitis. Through this, the investigators want to estimate the applicability of minimal change findings of reflux esophagitis to the clinic.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 20 years old patients who consent to revealing their medical information and be able to respond to questionnaires regarding the symptom.
- •Patients who had shown the reflux esophageal minimal change in the endoscopic finding: the reflux esophagitis
排除标准
- •Patients who had shown the mucosal break or barrett esophagus at gastric mucosal barrier or lower oesophagus in endoscopic findings
- •Patient with a diagnosis of gastroesophageal reflux disease and who have received medication treatment
- •Patient who had received H2-receptor antagonists, prostaglandin, PPI, NSAIDs or aspirin, high dose steroid and anticoagulants for at least 5 consecutive days in the 4-week period immediately preceding the diagnostic endoscopy
- •Patients with a history of operation due to gastrointestinal disease, malignancy, alcoholism, pregnancy (in female), breast feeding (in female) or systemic disease
结局指标
主要结局
To investigate significant minimal change endoscopic finding of reflux esophagitis diagnosis
时间窗: Significant minimal change endoscopic finding for gastroesophageal reflux disease diagnosis
次要结局
- To establish the probability model of diagnosing gastroesophageal reflux disease based on minimal change endoscopic findings through definition of significant minimal change endoscopic findings of gastroesophageal reflux disease diagnosis.(at baseline -->this is a cross-sectional study)
研究者
研究点 (1)
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