A Study to Assess the Effectiveness of Esomeprazole 40 mg Once Daily in Subjects With Continuing Gastroesophageal Reflux Disease (GORD) Symptoms Following Treatment Wit a Previous Full Dose Proton Pump Inhibitor (PPI)

AstraZeneca14 个研究点分布在 1 个国家目标入组 100 人开始时间: 2006年9月最近更新: 2009年3月11日

适应症

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: 14
主要终点: The primary objective of this study is to assess the change in the frequency of heartburn from baseline value at entry to the end of the study, after 8-weeks treatment with esomeprazole 40mg compared to previous full dose treatment with a PPI daily

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to assess how patients with gastro-oesophageal reflux disease (heartburn) who are currently receiving treatment with a proton pump inhibitor but are still experiencing symptoms will benefit from a change in treatment.

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

•Persisting symptoms of GORD despite previous treatment with a full dose proton pump inhibitor
•Informed consent
•Over 18 years of age

排除标准

•Current course of Proton Pump inhibitor treatment for more than 8 weeks prior to enrolment in the study;
•More than 1 other course of PPI treatment in the previous 12 month;
•Previous use of esomeprazole;
•Presence of alarm symptoms.

结局指标

主要结局

The primary objective of this study is to assess the change in the frequency of heartburn from baseline value at entry to the end of the study, after 8-weeks treatment with esomeprazole 40mg compared to previous full dose treatment with a PPI daily

次要结局

Change in frequency and severity of heartburn, epigastric pain and acid regurgitation after 4 and 8 weeks treatment from baseline value at study entry
Change in symptom control from baseline to 4 and 8 weeks using QOL questionnaires

研究者

发起方

AstraZeneca

申办方类型

Industry

研究点 (14)

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