NCT02386007Unknown2 期
A Double-blind, Multicenter, Randomized Phase 2a Study to Evaluate Optimum Dosage and Stability of DW-3101 in Korean Patients With Gastric Inflammation
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 主要终点
- The change of gastric erosion score
研究概览
简要总结
The purpose of this study is to find optimum dosage of DW-3101 by evaluating efficacy and safety of each dosage group in Korean patients with acute and chronic gastric inflammation.
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
- Triple (Participant, Care Provider, 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
- •Adult males/females aged 20~75 years
- •Patients detected over 1 erosion who diagnosed as acute or chronic gastric inflammation by gastrscopy in 7days before administration of experimental agents
- •Subjects who voluntarily agree to participate in this clinical test with written consent
排除标准
- •Patients impossible gastroscopy
- •In case accompanied with gastric ulcer(scar excepted) or reflux esophagitis
- •Patients who had stomach or esophagus surgery to inhibit gastric acid secretion (tresis or appendicectomy surgery excluded)
- •Patients with malignant tumor on digestive organ
- •Patients with blood clot(cerebral thrombosis, myocardial infarction, septic thrombophlebitis) and who have antithrombotic agents (eg. warfarin)
研究组 & 干预措施
DW-3101_600mg
Experimental
600mg a day
干预措施: DW-3101_600mg (Drug)
DW-3101_150mg
Experimental
150mg a day
干预措施: DW-3101_150mg (Drug)
DW-3101_300mg
Experimental
300mg a day
干预措施: DW-3101_300mg (Drug)
a tablet same as experimental agents in formation and shape
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
The change of gastric erosion score
时间窗: 14day±3
The erosion score is evaluated by gastroscopy. Erosion score The number of erosion 1. 0 2. 1\~2 3. 3\~5 4. More than 6 If patient's erosion score is decreased by 50% compared with erosion score before clinical dosing, we count it as effectiveness.
次要结局
未报告次要终点
研究者
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