NCT05786807招募中4 期
Effect of H. Pylori Eradication on Alleviating Symptoms in Functional Dyspepsia Patients: A Multicenter, Comparative 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
- 315
- 试验地点
- 1
- 主要终点
- Rate of disappearance of dyspepsia symptoms
研究概览
简要总结
In patients with Helicobacter pylori-positive functional dyspepsia, long-term follow-up for 6 months after standard triple therapy first-line eradication treatment, the rate of symptom disappearance and degree of improvement of functional dyspepsia were confirmed through changes in symptom scores and changes in drug usage, and eradication treatment The purpose of this study is to confirm the rate of symptom disappearance according to the results.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female outpatients between the ages of 19 and 75
- •Who have symptoms of functional dyspepsia (early fullness, postprandial discomfort, epigastric pain, epigastric soreness) that correspond to Rome criteria 4 (diagnostic criteria questionnaire)
排除标准
- •Small intestine and large intestine disease within 6 months of the screening visit (Visit 1)
- •liver, pancreatobiliary disease within 6 months of the screening visit (Visit 1)
- •peptic ulcer within 6 months of the screening visit (Visit 1)
研究组 & 干预措施
Tegoprazan 50mg
Experimental
single group
干预措施: K-CAB (Drug)
结局指标
主要结局
Rate of disappearance of dyspepsia symptoms
时间窗: Day 176
Rate of disappearance of dyspepsia symptoms after 6 months of eradication treatment
次要结局
- Improvement rate of dyspepsia symptoms(Day 92, Day 176)
- Number of days of dyspepsia drug administration(Day 92, Day 176)
研究者
Suck Chei Choi
Coordinating Investigator
Wonkwang University Hospital
研究点 (1)
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