NCT06430047招募中4 期
The Role of an EsoDuo® to Control Reflux Symptoms Related to the Acid; a Multicenter, Open-labeled, Phase 4 Study [RACER Study]
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- The time taken to control the symptoms of GERD
研究概览
简要总结
Clinical Trial to Evaluate the Effects of EsoDuo® in Controlling Reflux Symptoms Related to the Acid
详细描述
The Role of an EsoDuo® to Control Reflux Symptoms Related to the Acid; a Multicenter, Open-labeled, Phase 4 Study [RACER Study]
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female aged ≥ 19 years
- •Patients diagnosed with non-erosive reflux disease or mild erosive reflux disease
- •Episode of heartburn the GERD symptom(either heartburn or gastric acid reflux)
排除标准
- •Surgery history on stomach or esophagus
- •Barrett's esophagus (over 3cm), esophageal varices, esophageal stricture, esophageal achalasia, eosinophilic esophagitis, and primary motility disorders
- •Patients diagnosed with Grade C or Grade D according to the LA Classification system during upper gastrointestinal endoscopy
- •Patients with a history of malignancy within the past 5 years prior to the screening visit (Visit 1)
- •Patients who have taken prohibited concomitant medications within 14 days prior to the screening visit or require continuous administration of prohibited medications during the trial period.
- •Clinically significant Abnormal Lab test
- •Pregnant woman, Breastfeeding woman.
研究组 & 干预措施
Experimental Group
Experimental
干预措施: EsoDuo® Tablet (Drug)
结局指标
主要结局
The time taken to control the symptoms of GERD
时间窗: 2 weeks after the clinical trial participation
the symptoms of GERD : heartburn or acid reflux
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
4 期
Randomized, Double Blind, Placebo Control Trial to Evaluate the Efficacy of Wu-Chu-Yu Tang on Gastroesophageal Reflux Disease (GERD)Gastroesophageal Reflux DiseaseNCT01822106China Medical University Hospital90
尚未招募
不适用
Zuojin Wan Combined With Woonosan Fumarate for the Treatment of GRD Combined With DepressionGastroesophageal Reflux DiseaseDepressionNCT06481787Nanjing First Hospital, Nanjing Medical University300
尚未招募
不适用
Thorcolumbar Kyphosis Patients With GERDthe GERD OccurenceNCT04521985National Taiwan University Hospital30
已完成
不适用
Benesco for reflux symptoms: efficacy and mechanism of actioHearburnpyrosis10017977NL-OMON54012Academisch Medisch Centrum108
已完成
4 期
Chronic Posterior Laryngitis With Suspected Laryngopharyngeal RefluxChronic Posterior Laryngitis (CPL)NCT00628667AstraZeneca120