NCT03184402已完成3 期
Efficacy and Safety of DWJ1252 in the Treatment of Functional Dyspepsia: A Multicenter, Randomized, Double-blind, Active-controlled Study (PART 2)
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2017年4月24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
- 已完成
- 发起方
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- The change from baseline in GIS (Gastrointestinal Symptom Score)
研究概览
简要总结
The purpose of this study is to evaluate the Efficacy and Safety of DWJ1252 in treatment of Functional Dyspepsia.
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 and female of at least 19 years old
- •Patient with functional dyspepsia met the ROME III criteria
排除标准
- •Patients with previous gastrointestinal surgery
- •Patients with history of gastrointestinal bleeding, mechanical obstruction, perforation
- •Patients with history of gastrointestinal cancer
研究组 & 干预措施
DWJ1252
Experimental
干预措施: DWJ1252 (Drug)
DWJ1252
Experimental
干预措施: Placebo of Gasmotin (Drug)
Gasmotin
Active Comparator
干预措施: Gasmotin (Drug)
Gasmotin
Active Comparator
干预措施: Placebo of DWJ1252 (Drug)
结局指标
主要结局
The change from baseline in GIS (Gastrointestinal Symptom Score)
时间窗: At 4 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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