NCT00206180已完成4 期
A Multicenter, Double-Blind, Randomized Trial of the Relationship of Intragastric Acid Control and Healing Status of Moderate and Severe Erosive Esophagitis After Treatment With Esomeprazole Magnesium (NEXIUM®) 10 mg and 40 mg Once Daily
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
- 120
- 试验地点
- 38
- 主要终点
- To determine the relationship between 24-hour intragastric pH at Day 5 and healing status of moderate to severe erosive esophagitis, after 4 weeks of treatment with 2 doses of esomeprazole magnesium.
研究概览
简要总结
The purpose of this study is to decide if controlling stomach acid is related to healing of erosive esophagitis after treatment with esomeprazole magnesium (NEXIUM®) 10 mg and 40 mg once daily.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or non-pregnant, non-lactating female patients between the ages of 18 and 75 years
- •Patients must have moderate to severe erosive esophagitis
排除标准
- •Significant gastrointestinal bleeding
- •Severe heart, lung, liver or kidney disease
- •Esophagitis not related to acid reflux
结局指标
主要结局
To determine the relationship between 24-hour intragastric pH at Day 5 and healing status of moderate to severe erosive esophagitis, after 4 weeks of treatment with 2 doses of esomeprazole magnesium.
次要结局
- Secondary outcomes and the relationship to pH will also be assessed.
研究者
研究点 (38)
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