NCT00635414已完成4 期
An Open, Randomized, Two-way Crossover Study Comparing the Effect of 40mg Esomeprazole Administered Orally and Intravenously as a 15 Minute Infusion on Basal and Pentagastrin-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
- The maximal acid output (MAO) during pentagastrin stimulation after 10 days administration of 40 mg esomeprazole for both study periods.
研究概览
简要总结
This study looks at the effect on basal and pentagastrin-stimulated acid output of 40 mg Esomeprazole (Nexium) administered orally and intravenously as a 15-minute infusion to people 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 at least 2 days of the past 7 days prior to screening, with or without a history of EE or a documented diagnosis of GERD within 6 months prior to screening, with or without a history of EE.
- •Body mass index (BMI) of ≥18.5 and ≤35 kg/m
- •[BMI will be calculated using the following formula: weight (kg)/height (m)2.]
- •Able to communicate with the investigator and to understand and comply with the requirements of the study.
排除标准
- •History of esophageal, gastric, or duodenal surgery, except for simple closure of an ulcer.
- •History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.
- •Any significant "alarm symptoms", within the past 6 months, such as, unintentional weight loss, gastrointestinal bleeding, jaundice or any other sign indicating serious or malignant disease.
- •Abnormal lab test results, as indicated in the protocol.
- •Other diseases, as indicated in the protocol.
研究组 & 干预措施
1
Experimental
40mg administered orally
干预措施: Esomeprazole (Drug)
2
Experimental
15 minute intravenous infusion
干预措施: Esomeprazole (Drug)
结局指标
主要结局
The maximal acid output (MAO) during pentagastrin stimulation after 10 days administration of 40 mg esomeprazole for both study periods.
时间窗: MAO will be assessed after 10 days of treatment (Day 11 or Day 20)
次要结局
- Basal acid output (BAO) after 10 days administration of 40 mg esomeprazole for both study periods. (Day 11 or Day 20)(BAO will be assessed after 10 days of treatment)
- To compare MAO when switching (after Day 2 in the second study period versus after Day 10 in the first study period) from oral to intravenous dosing and from intravenous to oral dosing.(Assessments at Day 2 and after Day 10 (Day 11 or Day 20))
- To evaluate the safety of intravenous esomeprazole in subjects with symptoms of GERD.(Safety assessments throughout the study)
研究者
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