Comparison of the Gastric Acid Suppressive Effects of Esomeprazole and Generic Omeprazole
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Median intragastric pH and percentage of time that intragastric pH is above 4
研究概览
简要总结
Proton pump inhibitors (PPI) are used to decrease stomach acid secretion. A generic form of omeprazole, one of the PPIs, is on the market. With cheaper than brand name PPIs, it is unclear whether generic omeprazole is as effective clinically. This study compares generic omeprazole with half-dose esomeprazole, the strongest brand name PPI. The half-dose esomeprazole is in fact cheaper than generic omeprazole. Healthy volunteers will take each medication in turn for 7 days and their stomach acid will be measured while taking each medication. We hypothesize that half-dose esomeprazole is better at suppressing stomach acid than generic omeprazole.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy, non-smoking volunteers older than 18 years of age
排除标准
- •history of gastrointestinal disease
- •known infection
- •previous eradication of Helicobacter pylori
- •any prescription or over the counter antacid medication
- •pregnant and lactating women
研究组 & 干预措施
1
- esomeprazole 20mg po once per day for 7 days
- 24hr pH study on day 7
- followed by washout for 7 days
- generic omeprazole 20mg po once per day for 7 days
- 24hr pH study on day 7
干预措施: Esomeprazole first (Drug)
2
- generic omeprazole 20mg po once per day for 7 days
- 24hr pH study on day 7
- followed by washout for 7 days
- esomeprazole 20mg po once per day for 7 days
- 24hr pH study on day 7
干预措施: Generic omeprazole first (Drug)
结局指标
主要结局
Median intragastric pH and percentage of time that intragastric pH is above 4
时间窗: 24 hours
次要结局
- Nocturnal acid breakthrough, defined as at least 60 continuous minutes of intragastric pH below 4 occurring between 10pm and 6 am and adverse events(24 hours)
研究者
Dr. Adriana Lazarescu
GI Fellow
Queen's University