Effect of Proton Pump Inhibitor and Mosapride on Acid Pocket in Gastroesophageal Reflux Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- Size(cm2) of the acid pocket between PPI+placebo group and PPI+mosapride group
研究概览
简要总结
The gastric acid pocket is believed to be the reservoir from which acid reflux events originate. The risk for acidic reflux is mainly determined by the position of the gastric acid pocket. Little is known about how changes in position and size of the acid pocket contribute to the therapeutic effect of proton pump inhibitors(PPI) plus mosapride in patients with gastroesophageal reflux disease. Investigators will conduct a prospective randomized, single blind and placebo-controlled clinical trial to evaluate the hypothesis that mosapride affecting gastric motility might reduce gastro-esophageal reflux by changing the acid pocket position and size.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with diagnosed GERD(gastro-esophageal reflux disease), defined by the presence of oesophagitis obtained during a previous upper endoscopy or typical GERD symptoms(heartburn, acid reflux).
排除标准
- •who had organic gastrointestinal disease including inflammatory bowel disease, cancer and ulcer
- •who took drugs which could affect evaluation of the treatment; other PPIs, H2RAs(H2 receptor antagonists), prokinetics,mucosal protective agents, antacids, cholinergic and anticholinergic agents, and antidepressants for at least 4 weeks prior to study start
- •who had severe systemic diseases including hepatic and nephrotic disease
- •who had previous gastrectomy history
- •who was in state of pregnancy
研究组 & 干预措施
PPI + mosapride group
After diagnosis(GERD), patient of this group will be taken proton pump inhibitor (40mg) plus mosapride for 4weeks. After then, patient of this group will be undergo upper endoscopy and scintigraphy.
干预措施: Administration of study drug (esomeprazole, mosapride) (Drug)
PPI + mosapride group
After diagnosis(GERD), patient of this group will be taken proton pump inhibitor (40mg) plus mosapride for 4weeks. After then, patient of this group will be undergo upper endoscopy and scintigraphy.
干预措施: upper endoscopy, scintigraphy (Procedure)
PPI + placebo group
After diagnosis(GERD), patient of this group will be taken proton pump inhibitor (40mg) plus placebo drug of mosapride for 4weeks. After then, patient of this group will be undergo upper endoscopy and scintigraphy.
干预措施: Administration of study drug (esomeprazole, placebo tablet) (Drug)
PPI + placebo group
After diagnosis(GERD), patient of this group will be taken proton pump inhibitor (40mg) plus placebo drug of mosapride for 4weeks. After then, patient of this group will be undergo upper endoscopy and scintigraphy.
干预措施: upper endoscopy, scintigraphy (Procedure)
结局指标
主要结局
Size(cm2) of the acid pocket between PPI+placebo group and PPI+mosapride group
时间窗: After 4weeks of drug treatment(PPI+placebo vs. PPI + mosapride)
The size of the acid pocket will be determined by drawing an area of interest over the acid pocket in the proximal stomach in images(scintigraphy) taken at 10-minute intervals.
Location(cm) of the acid pocket between PPI+placebo group and PPI+mosapride group
时间窗: After 4weeks of drug treatment(PPI+placebo vs. PPI + mosapride)
Measurements of the distances between the acid pocket and the diaphragm will be make through a straight line in a planar posterior view of the stomach in images(scintigraphy)
次要结局
- Improvement of reflux symptom(After 4weeks of drug treatment(PPI+placebo vs. PPI + mosapride))
研究者
Hyojin Park
Department of Internal Medicine
Gangnam Severance Hospital