NCT06151210已完成3 期
A Multicenter, Randomized, Double-blind, Active-controlled, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DA-5219 in Patients With Acute or Chronic Gastritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 467
- 试验地点
- 1
- 主要终点
- Improvement rate of gastric mucosal erosion
研究概览
简要总结
This study is to evaluate the efficacy and safety of DA-5219 in patients with acute or chronic gastritis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Men or women aged ≥ 19 years and ≤ 75 years
- •Subjects who diagnosed with acute or chronic gastritis by upper gastrointestinal endoscopy within 7days prior to the randomization
- •Subjects who have one or more erosions identified on upper gastrointestinal endoscopy within 7days prior to the randomization
- •Subjects who voluntarily signed a consent form
排除标准
- •Ineligible for upper gastrointestinal endoscopy
- •Subjects with active or healing gastroduodenal ulcer, reflux esophagitis, Barrett's esophagus, or gastroesophageal varices identified on upper gastrointestinal endoscopy within 7days prior to the randomization
- •Subjects with hypersensitivity to investigational drugs and similar drugs
- •Pregnant or breastfeeding women
研究组 & 干预措施
DA-5219
Experimental
administered for 2weeks(DA-5219 + Stillen® Tab placebo)
干预措施: DA-5219 (Drug)
DA-5219
Experimental
administered for 2weeks(DA-5219 + Stillen® Tab placebo)
干预措施: Stillen® Tab Placebo (Drug)
Stillen® Tab
Active Comparator
administered for 2weeks(Stillen® Tab + DA-5219 placebo)
干预措施: Stillen® Tab (Drug)
Stillen® Tab
Active Comparator
administered for 2weeks(Stillen® Tab + DA-5219 placebo)
干预措施: DA-5219 Placebo (Drug)
结局指标
主要结局
Improvement rate of gastric mucosal erosion
时间窗: Change from baseline at 2 weeks
次要结局
- Cure rate for gastric mucosal erosion(Change from baseline at 2 weeks)
- Improvement rate for gastric mucosal bleeding(Change from baseline at 2 weeks)
- Improvement rate for gastric subjective symptoms(Change from baseline at 2 weeks)
- Cure rate for gastric mucosal edema(Change from baseline at 2 weeks)
- Improvement rate for gastric mucosal erythema(Change from baseline at 2 weeks)
研究者
研究点 (1)
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