Omepral® Tablets Mega-study to Investigate the Efficacy on Various Type of Acid Reflux Related Symptoms and QOL, and Epidemiology in Patients With Erosive Esophagitis in Daily Medical Practice

AstraZeneca0 个研究点目标入组 10,703 人开始时间: 2007年6月最近更新: 2009年7月15日

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: 10,703
主要终点: Patients symptom evaluated by investigator

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

This open label, non-interventional study is to compare the efficacy of Omepral® tablet and any other treatments excepting proton pump inhibitors (PPIs) for the treatment of various type of acid reflux related symptoms in patients with reflux esophagitis.

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 newly diagnosed as erosive esophagitis or history of erosive esophagitis confirmed by endoscopy.
•Patients who answered questionnaires of quality of life (QOLRAD-J), symptom severity and frequency and treatment satisfaction.
•During the past 1 week , patients who have either two days or more with heartburn or acid taste in the mouth of any severity

排除标准

•Patients receiving treatment with proton pump inhibitors, which make stomach acid decreased during the last 4 weeks prior to enrolment.
•Patients who cannot answer questionnaires of quality of life (QOLRAD-J), symptom severity and frequency and treatment satisfaction.
•Patients included previously in this study.

结局指标

主要结局

Patients symptom evaluated by investigator

时间窗: at entry, 4 weeks and 8 weeks

Patients reported symptom

时间窗: at entry, 4 weeks and 8 weeks

次要结局

Patients reported outcome score(at entry, 4 weeks and 8 weeks)
Adverse event(8 weeks)

研究者

发起方

AstraZeneca

申办方类型

Industry

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