A Multi-center, Randomized, Double-blind, Active-controlled, Non-inferiority, Phase 3 Study to Evaluate the Efficacy and Safety of MCT-SR in Patients With Gastritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 392
- 试验地点
- 1
- 主要终点
- Endoscopic Improvement Rate
研究概览
简要总结
This is a multi-center, randomized, double-blind, active-controlled, non-inferiority, phase 3 study to evaluate the efficacy and safety of MCT-SR in patients with gastritis.
详细描述
To contribute greater treatment compliance and patient convenience, the rebamipide SR formulation has been developed.
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
- 19 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult males and females aged ≥19 and <75 years
- •Patients diagnosed with acute or chronic gastritis by gastroscopy with at least 1 erosion confirmed by gastroscopy within 7 days prior to the first dose of the Investigational Product(IP)
排除标准
- •Patients ineligible for gastroscopy
- •Patients who took other drugs for treating gastritis within 2 weeks prior to the first dose of the IP.
- •Patients who have to continue taking drugs that may induce gastritis
- •Other clinically significant medical or psychiatric findings that the investigator considers inappropriate for the study
研究组 & 干预措施
MCT-SR
Drug: MCT-SR 2 times/day for 2 weeks
干预措施: MCT-SR (Drug)
MCT-SR
Drug: MCT-SR 2 times/day for 2 weeks
干预措施: Mucosta Tab. (Drug)
Mucosta Tab.
Drug: Mucosta Tab. 3 times/day for 2 weeks
干预措施: MCT-SR (Drug)
Mucosta Tab.
Drug: Mucosta Tab. 3 times/day for 2 weeks
干预措施: Mucosta Tab. (Drug)
结局指标
主要结局
Endoscopic Improvement Rate
时间窗: 2 weeks
The percentage of subjects with improvement refer to those with more than 50% improvement in erosion score on gastroscopy after treatment compared to the score before treatment.
次要结局
未报告次要终点