A Multi-centers, Randomized, Double-blinded, Parallel Study Study to Evaluate the Efficacy and Safety of Motilitone® in Patients With Functional Dyspepsia.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 389
- 试验地点
- 1
- 主要终点
- Subject global assessment by using 5-Likert scale and Binary outcome methods
研究概览
简要总结
This is a phase IV , comparative study to evaluate the efficacy and safety of Motiltone® in treatment of the patients with functional dyspepsia. The study is conducted with following methods: multi-centers, double blind, randomization, parallel. The subjects will receive Motilitone® or/and Pantoline®.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Roman III criteria
- •One or more conditions are applied: epigastralgia, burning feelings in the solar plexus early satiety, uncomfortable fullness
- •No organic lesion
排除标准
- •has been administered or was administered within a month
- •had a surgery that might affect gastrointestinal motility
- •Tegaserod
研究组 & 干预措施
Motilione®
30 mg is administered with a tablet of placebo (Pantoline®)
干预措施: Motilitone ® (Drug)
Pantoline®
40mg is administered with a tablet of Motilitone®
干预措施: Pantoline® (Drug)
Motilitone® and Pantoline®
Both drugs are administered at once
干预措施: Motilitone® and Pantoline® (Drug)
结局指标
主要结局
Subject global assessment by using 5-Likert scale and Binary outcome methods
时间窗: 6 weeks
5-Likert scale: 0: worse 1. similar 2. improved in some degree 3. considerably improved 4. completely cured Binary outcome: yes/no
次要结局
- Number of dyspepsia(indigestion) symptoms occurred (Counted daily)(6 weeks)
- Soreness of digestive symptoms (dyspepsia) evaluated its intensity on a scale of 1 to 5(6 weeks)
- Assessment of NDI-K Quality of Life(6 weeks)