NCT03284177已完成2 期
A Multicenter, Open-label Trial to Investigate the Safety of C13-CAC and the Relationship Among C13-CAC Breath Test, Gastric pH, and the Improvement of Symptoms in PPI Resistant GERD Patients
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 13
- 主要终点
- 13CO2 concentration in expired air.
研究概览
简要总结
To investigate the safety of C13-CAC and the relationship among C13-CAC breath test, gastric pH, and the improvement of symptoms by switching PPI in PPI resistant GERD patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •GERD patients who have been judged to require additional treatment to improve their symptoms by investigator or subinvestigator.
排除标准
- •Patients suspected to have hypothyroidism or hyperparathyroidism.
- •Patients with hypercalcemia
- •Patients with a history of gastric or duodenal surgery.
- •Patients who have received the eradication therapy of Helicobacter pylori within six months prior to participation of the study.
- •Patients with a prior or current history of Zollinger-Ellison syndrome.
- •Patients with a history of surgery or treatment affecting gastroesophageal reflux.
- •Patients who have been diagnosed with acute upper gastrointestinal bleeding or active gastric or duodenal ulcer within 30 days prior to participation of the study.
- •Patients with serious central nervous system disorders, cardiovascular disease, pulmonary disease, hepatic disease, renal disease, metabolic disease, gastrointestinal disorders, urinary disorders, endocrine disease, or blood dyspraxia.
- •Patients scheduled for surgery requiring hospitalization or required surgery during the study period.
- •Patients who have had either a prior or current history of chest pain due to heart disease or with chest pain suspected to have caused by heart disease within one year prior to participation of the study.
研究组 & 干预措施
C13-CAC
Experimental
干预措施: Calcium (13C)Carbonate (Drug)
C13-CAC
Experimental
干预措施: Gastric acid inhibitors (Drug)
C13-CAC
Experimental
干预措施: Gastric pH monitoring (Other)
结局指标
主要结局
13CO2 concentration in expired air.
时间窗: 5，10，15，20，25 and 30 minutes after C13-CAC administration.
Sensitivity and specificity of 13CO2 concentration in expired air for improvement of symptoms.
次要结局
- Gastric pH(1 hour prior to C13-CAC administration)
研究者
研究点 (13)
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