NCT05842408已完成3 期
A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of DA-5212 in Patients with Functional Dyspepsia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 384
- 试验地点
- 1
- 主要终点
- Change in NDI-K functional dyspepsia score
研究概览
简要总结
This study is to evaluate efficacy and safety of DA-5212 in patients with 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
- •Men or women ≥ 19 years of age
- •Patients who diagnosed with functional dyspepsia
- •Patients with no organic cause for digestive symptoms found by upper gastrointestinal endoscopy at screening visit
排除标准
- •Patients with organic disease or medical history that may cause dyspepsia within 6 months before screening visit
- •Patients who have a history of drugs or alcohol abuse and dependence within 6 months before screening visit
- •Patients with hypersensitivity to investigational drugs and similar drugs
- •Pregnant or breastfeeding women
研究组 & 干预措施
DA-5212
Experimental
administered once daily for 4weeks
干预措施: DA-5212 (Drug)
DA-5212-R
Other
administered once daily for 4weeks
干预措施: DA-5212-R (Drug)
结局指标
主要结局
Change in NDI-K functional dyspepsia score
时间窗: Change from baseline at 4 weeks
次要结局
- Change in overall treatment score of patients(Change from baseline at 4 weeks)
研究者
研究点 (1)
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