NCT01355276已完成3 期
A Randomized, Double-blind, Double-dummy, Active Drug Parallel Controlled, Multi-center Clinical Trial on the Efficacy and Safety of Cinitapride Tablets in the Treatment of Mild to Moderate 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
- 400
- 试验地点
- 13
- 主要终点
- Response rate of overall symptom improvement after 4-weeks treatment
研究概览
简要总结
The purpose of this study is to compare Cinitapride tablets with domperidone tablets (motilium), and to evaluate the efficacy and safety of Cinitapride tablets in the treatment of mild to moderate 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
干预措施: Cinitapride (Drug)
2
Active Comparator
干预措施: domperidone (Drug)
结局指标
主要结局
Response rate of overall symptom improvement after 4-weeks treatment
时间窗: 4 weeks
次要结局
- Percentage change of overall symptom score of functional dyspepsia from baseline after 2 and 4 weeks treatment(2 and 4 weeks)
- Response rate after 2 weeks treatment(2 weeks)
- Percentage change of individual symptom score (early satiety, discomfort with fullness after meal, flatulence, epigastric pain, epigastric burning, nausea, vomiting and belching) after 2 and 4 weeks treatment compared with the baseline(2 and 4 weeks)
- Changes of gastric emptying in some patients after 4-week treatment(4 weeks)
- Patient's global subjective assessment (Likert scale score) after 2 and 4 weeks treatment(2 and 4 weeks)
研究者
研究点 (13)
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