Treatment Response of Maintenance Dose of Proton Pump Inhibitor in Patients With Nonerosive Gatroesophageal Reflux Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Proportion of PAGI-SYM score (0-2) patients after 8 weeks of PPI(Esomezol)
研究概览
简要总结
For ERD(erosive reflux disease), which pathogenesis is mainly the acid reflux mechanism, primary treatment is therefore PPI. However, NERD(non-erosive reflux disease) is much more complex than ERD and there are more factors causing the typical symptoms. As a result, there is no consensus for the treatment of NERD besides using PPI similar to GERD(gastroesophageal reflux diseas). This study intent to evaluate the effect of PPI(Esomezol) on NERD patients and analyze the improvement of symptoms and the factors related to the result.
详细描述
(1) Among GERD patients, EGD(esophagogastroduodenoscopy) must be done before 6 months and must prove there is no erosive lesion. (2) During EGD, esophagus mucosa histology will be taken for evaluation. (3) For NERD patients, Esomezol is given once a day (before breakfast meal), for whole 8 weeks. (4) PAGI-SYM and HAD-K is evaluated and score just before the administration of PPI, 4weeks after and 8weeks after the study initiation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient over 19 years old
- •Patient with typical GERD symptom (heartburn or acid reflux more than once a week)
排除标准
- •Patient who received EGD since the past 6 months, and diagnosed as GERD endoscopically
- •Patient with active gastric/duodenal ulcer
- •Patient who received esophagus, stomach or duodenum surgery
- •Patient with hypersensitivity to esomezol®
- •Patient with no achieved agreement on the study from the guardian or patient himself.
研究组 & 干预措施
PPI
Esomezol®
干预措施: PPI (Drug)
结局指标
主要结局
Proportion of PAGI-SYM score (0-2) patients after 8 weeks of PPI(Esomezol)
时间窗: 8 weeks
Scoring the PAGI-SYM to analyze the satisfaction of symptoms (heartburn and regurgitation) after 8 weeks of PPI administration to NERD patients
次要结局
- The analysis of factors affecting the PAGI-SYM inculding immunolgic array and esophagus mucosal microbiota(8 weeks)