NCT01370525已完成3 期
A Phase III Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of 14 Day Treatment With Esomeprazole 20 mg Once Daily in Subjects With Frequent Heartburn
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment
研究概览
简要总结
This study will investigate the efficacy of esomeprazole 20 mg once a day in the treatment of frequent heartburn
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Males and non-pregnant ,non-lactating females 18 years or older
- •Experience heartburn at least 2 days a week
- •Having heartburn that has responded to heartburn medication
- •Must discontinue any current heartburn medications
排除标准
- •Having a history of erosive esophagitis verified by endoscopy
- •Having a history of GERD which was diagnosed by a physician
- •Inability to take study medication or complete the study and all study procedures
- •Subjects that have required more than one 14-day course of PPI treatment within the past 4 months
研究组 & 干预措施
Esomeprazole 20 mg
Experimental
干预措施: Esomeprazole (Drug)
Placebo
Placebo Comparator
干预措施: Esomeprazole (Drug)
结局指标
主要结局
Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment
时间窗: From randomization to day 14
次要结局
- Number of Subjects Reporting Heartburn 2 Days or Less During the 14 Days Randomized Treatment Period(From randomisation to day 14)
- Comparison of Number of Subjects With 0, 1, 2, 3 or 4 Days With no Heartburn Over Days 1 to 4 Between Esomeprazole 20 mg and Placebo(From randomisation to the day 14)
- Number of Subjects With Heartburn 1 Day or Less During the Final Week, Second Week, First Week of Treatment(From randomisation to day 14)
研究者
研究点 (1)
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