NCT04066530已完成3 期
A Randomized, Double-blinded, Active Controlled, Non-Inferiority, Multicenter, Phase III Clinical Trial to Evaluate the Efficacy and Safety of AD-203 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
- 475
- 试验地点
- 1
- 主要终点
- A percentage of subjects showed improvement of stomach erosions by the endoscopy.
研究概览
简要总结
This is a multicenter, active-controlled , randomized, double-blinded, paralleled group clinical study to evaluate the efficacy and safety of AD-203 to demonstrate the non-inferiority of AD-203 compared with Mucosta tab. 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age is over 20 years old, under 75 years old, men or women
- •Patients diagnosed with acute or chronic gastritis by gastroscopy
排除标准
- •Patients who is impossible to receive gastroscopy
- •Patients taking other investigational drugs or participating in other clinical studies in 3 months prior to screening visit
研究组 & 干预措施
AD-203
Experimental
干预措施: AD-203 (Drug)
Mucosta tab.
Active Comparator
干预措施: Mucosta tab. (Drug)
结局指标
主要结局
A percentage of subjects showed improvement of stomach erosions by the endoscopy.
时间窗: 2 weeks
Evaluate the improvement rate of "Very much improved' and "Much improved" of subjects with stomach erosions. The definition of "Very Much Improved" is the subjects showed score changed from 4 to 1 or from 3 to 1. And, "Much improved" means the subject showed score changed from 4 to 2 or from 2 to 1.
次要结局
未报告次要终点
研究者
研究点 (1)
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