NCT00637559已完成4 期
A Multicenter, Double-blind, Three-way Crossover Intraesophageal and Intragastric pH Study of Three Esomeprazole Treatment Regimens in Documented Barrett's Esophagus Patients
适应症
干预措施
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
- 50
- 主要终点
- To compare the total percent time during the 24-hour monitoring period that gastric pH is above 4.0 at steady state in patients when taking: esomeprazole 40mg twice daily, esomeprazole 40mg three times daily, esomeprazole 20 mg three times daily.
研究概览
简要总结
This study looks the intragastric and intraesophageal pH in patients with documented Barrett's esophagus whilst taking esomeprazole 40mg twice daily, esomeprazole 40mg three times daily, esomeprazole 20 mg three times daily.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
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
- •Must have a previously established, biopsy-proven diagnosis of Barrett's esophagus with segment length greater than 3cm, with no dysplasia or adenocarcinoma within the previous 12 months
排除标准
- •A history of esophageal, gastric, or duodenal surgery, including anti-reflux surgery or endoscopic anti-reflux procedures, except for simple closure of a gastric or duodenal ulcer.
- •History of various gastrointestinal diseases - please see investigator for full list.
- •Evidence of any malignant disease in the last 5 years, except minor superficial skin disease.
- •Unstable diabetes mellitus. Stable on a controlled diet, oral agents or insulin are acceptable.
研究组 & 干预措施
1
Experimental
40mg twice daily
干预措施: Esomeprazole Magnesium (Drug)
2
Experimental
40mg three times daily
干预措施: Esomeprazole Magnesium (Drug)
3
Experimental
20mg three times daily
干预措施: Esomeprazole Magnesium (Drug)
结局指标
主要结局
To compare the total percent time during the 24-hour monitoring period that gastric pH is above 4.0 at steady state in patients when taking: esomeprazole 40mg twice daily, esomeprazole 40mg three times daily, esomeprazole 20 mg three times daily.
时间窗: pH measured on Day 5
次要结局
- Compare total percent time distal esophageal pH is above 4.0 at steady state for each treatment period.(pH measured)
研究者
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