A Pilot Study to Assess Healing of Erosive Esophagitis in Patients Randomized to Conventional PPI Doses Versus Dosing Based on CYP2C19 Genotype
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- Improvement of Los Angeles (LA) classification of Erosive Esphagitis (EE) grade
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age ≥ 18 years
- •diagnosis of Gastroesophageal Reflux Disease (GERD) scheduled for an esophagogastroduodenoscopy (EGD)
- •patients diagnosed with Erosive Esophagitis on endoscopy (EGD).
排除标准
- •age <18 years
- •diagnosed with non-erosive reflux disease (NERD)
- •pregnancy
研究组 & 干预措施
Intervention
proton pump inhibitor dose based on CYP2C19 phenotypes
干预措施: CYP2C19 based dosing Proton Pump Inhibitors (Drug)
Control
conventional proton pump inhibitor dose of Pantoprazole 40 mg once or twice daily
干预措施: Conventional proton pump inhibitor dose (Drug)
结局指标
主要结局
Improvement of Los Angeles (LA) classification of Erosive Esphagitis (EE) grade
时间窗: 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.
次要结局
未报告次要终点