PPI Dosing Per CYP2C19 Genotype
A Pilot Study to Assess Healing of Erosive Esophagitis in Patients Randomized to Conventional PPI Doses Versus Dosing Based on CYP2C19 Genotype
This study is being done to determine if the dosing of proton pump inhibitor (PPI) medication based on CYP2C19 genotype-derived phenotype leads to improved healing of erosive esophagitis compared to conventional PPI medication dosing.
研究概览
地位
条件
研究类型
注册 (估计的)
阶段
- 第四阶段
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- age ≥ 18 years
- diagnosis of Gastroesophageal Reflux Disease (GERD) scheduled for an esophagogastroduodenoscopy (EGD)
- patients diagnosed with Erosive Esophagitis on endoscopy (EGD).
Exclusion Criteria:
- age <18 years
- diagnosed with non-erosive reflux disease (NERD)
- pregnancy
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Intervention
proton pump inhibitor dose based on CYP2C19 phenotypes |
Pantoprazole dosing based on CYP2C19 phenotypes |
|
有源比较器：Control
conventional proton pump inhibitor dose of Pantoprazole 40 mg once or twice daily |
conventional PPI dose of Pantoprazole 40 mg once or twice daily |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Improvement of Los Angeles (LA) classification of Erosive Esphagitis (EE) grade
大体时间：8 weeks
|
Assessment of erosive esophagitis grade to determine healing in both arms. Healing would be measured by endoscopic regression of errosive esophagitis (EE) to a lower degree of inflammation. Previously assigned baseline numerical values per the LA classification of EE will be used to calculate the degree of healing in each arm at the 8th week follow up, e.g. LA grade D (initial EGD) to LA grade A (repeat EGD) would yield a score of 3 (LA D [5] - LA A [2]). A higher score hence indicating superior healing of EE. |
8 weeks
|
合作者和调查者
调查人员
- 首席研究员：Ruchir Puri, MD、University of Florida
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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