NCT01578811已完成2 期
Study to Assess the Efficacy and Safety of SK-MS10 in Subjects With Acute and Chronic Gastritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Improvement rates of erosive gastritis according to the sydney classification
研究概览
简要总结
The purpose of this study is to Assess the Efficacy and Safety of SK-MS10 in subjects With acute and 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
- •Have been diagnosed as erosive gastritis by endoscopy within 1 weeks before enrollment.
- •Patients who voluntarily signed written informed consent may participate in the study.
排除标准
- •Pregnant or lactating female.
- •Patients have gastric ulcer, duodenal ulcer and GERD.
- •Use of any proton pump inhibitor, H2-receptor antagonist, muscarine receptor antagonist and gastrin receptor antagonist within 2 weeks before initiating study drug therapy
- •Patients requiring corticosteroid therapy
- •Severe neurological or psychological disease
- •History of allergic reaction to the medications used in this study
- •Use of other investigational drugs within 30 days prior to the study.
- •Patients that investigators consider ineligible for this study
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
SK-MS10 160mg t.i.d
Experimental
干预措施: SK-MS10 (Drug)
SK-MS10 320mg t.i.d
Experimental
干预措施: SK-MS10 (Drug)
结局指标
主要结局
Improvement rates of erosive gastritis according to the sydney classification
时间窗: Change from Baseline in the grade of erosive gastritis at 2 weeks
次要结局
- Healing rates of erosive gastritis according to the sydney classification(Change from Baseline in the grade of gastric erosions at 2 weeks)
- Improvement rates of erosive gastritis by estimated the number of erosion(Change from Baseline in the number of gastric erosions at 2 weeks)
- Healing rates of edema according to the sydney classification(Change from Baseline in the grade of edema at 2 weeks)
- Improvement rates of erythema according to the sydney classification(Change from Baseline in the grade of erythema at 2 weeks)
- Improvement rates of hemorrhage according to the Scandinavian Journal of Gastroenterology - Supplement(Change from Baseline in the grade of hemorrhage at 2 weeks)
- Improvement rates of symptoms using Korean NDI(Questionaire at baseline and then week 2)
研究者
研究点 (1)
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