NCT00625495已完成4 期
An Open, Randomised Two Way Crossover Study Comparing the Effects of 40mg of Esomeprazole Adminstered Orally and Intravenously as a 3 Minute Injection on Basal and Pentrigastrin-stimulated Acid Output in Subjects With Symptoms of Gastroesophageal Reflux Disease (GERD)
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
- 60
- 主要终点
- To compare the maximum acid output during pentagastrin stimulation after 10 days of Nexium dosing administered orally with 10 days dosing via intravenous administration.
研究概览
简要总结
The purpose of this study is to examine the effects of Nexium at a dose of 40mg administered orally compared to intravenously on the maximum acid output in subjects with symptoms of Gastroesophageal reflux disease (GERD).
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
- None
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
- •Heartburn on 2 out of the last 7 days prior to screening or a diagnosis of GERD (with or without a diagnosis of Erosive eosphagitis).
- •Body Mass Index within the limits specified in the protocol
排除标准
- •History of esophageal, duodenal or gastric surgery
- •History of severe liver disease.
- •Any other significant disease or pathology judged to be clinically significant by the investigator
研究组 & 干预措施
1
Experimental
IV Nexium
干预措施: Esomeprazole (Drug)
2
Experimental
Oral Nexium
干预措施: Esomeprazole (Drug)
结局指标
主要结局
To compare the maximum acid output during pentagastrin stimulation after 10 days of Nexium dosing administered orally with 10 days dosing via intravenous administration.
时间窗: Every 10 days
次要结局
- To compare basal acid output at steady state and when switching between Oral and IV adminstration of Nexium.(Post Day 10)
- To compare maximum acid output when switching between Oral and IV adminstration of Nexium(Post Day 10)
- Safety assessment via adverse event recording(At each visit)
研究者
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