NCT03184415终止3 期
A Multi-Center, Randomized, Parallel, Double-Blind, Phase III Clinical Trial to Compare the Efficacy and Safety of DWC20155/DWC20156 Combination Therapy With DWC20155 or DWC20156 Monotherapy in Patients With Gastritis
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2017年7月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Improvement rates of stomach erosions by the endoscopy
研究概览
简要总结
THe purpose of this study is to evaludate the Efficacy and Safety of DWC20155/DWC20156 Combination Therapy in Patients with 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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male of female of at least 19 years old
- •Patients diagnosed with acute or chronic gastritis by gastroscopy
- •Patients with one or more erosions found by gastroscopy
排除标准
- •Patients with peptic ulcer and gastroesophageal reflux disease
- •Patients with previous gastrointestinal surgery
- •Patients with history of gastrointestinal cancer
研究组 & 干预措施
DWC20156 Monotherapy
Active Comparator
干预措施: DWC20156 (Drug)
DWC20155/DWC20156 Combination Therapy
Experimental
干预措施: DWC20155 (Drug)
DWC20155/DWC20156 Combination Therapy
Experimental
干预措施: DWC20156 (Drug)
DWC20155/DWC20156 Combination Therapy
Experimental
干预措施: placebo of DWC20155 (Drug)
DWC20155 Monotherapy
Active Comparator
干预措施: DWC20155 (Drug)
DWC20155 Monotherapy
Active Comparator
干预措施: placebo of DWC20155 (Drug)
DWC20155 Monotherapy
Active Comparator
干预措施: placebo of DWC20156 (Drug)
DWC20156 Monotherapy
Active Comparator
干预措施: placebo of DWC20155 (Drug)
结局指标
主要结局
Improvement rates of stomach erosions by the endoscopy
时间窗: At 2 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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