NCT02831543Unknown3 期
Clinical Trial to Assess the Efficacy and Safety of Combination Therapy of Motireb 5/100 mg in Functional Dyspepsia Patients.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 354
- 试验地点
- 1
- 主要终点
- The responder ratio of GOS(Global Overall Symptom)
研究概览
简要总结
A phase Ⅲ, multi-center, randomized, double-blinded, placebo and active comparator clinical trial to assess the efficacy and safety of combination therapy of Motireb 5/100 mg in functional dyspepsia patients.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female aged 19 years or older
- •Patient with functional dyspepsia met the ROME III criteria or symptom assessment form
排除标准
- •Patient with peptic ulcer or gastroesophageal reflux disease
- •Patients with previous gastrointestinal surgery
- •Patients with history of gastrointestinal bleeding, mechanical obstruction, perforation
- •Patients with history of gastrointestinal cancer
- •Patients with pancreatic disease (pancreatitis, pancreatic cancer, etc), biliary disease, inflammatory bowel disease, acute gastritis.
- •Patients with Zollinger-Ellison syndrome
- •Patients with irritable bowel syndrome
- •Pregnant or lactating women
- •Patients with hepatic abnormality
- •Patients with renal dysfunction or chronic kidney disease
- •Patients who are judged by the investigators to be unsuitable to participate in the clinical trial.
研究组 & 干预措施
Motireb 5/100 mg t.i.d
Experimental
Motireb 5/100 mg t.i.d + Placebo of Mosapride citrate t.i.d
干预措施: Motireb 5/100 mg (Drug)
Mosapride citrate t.i.d
Active Comparator
Placebo of Motireb 5/100 mg t.i.d + Mosapride citrate t.i.d
干预措施: Mosapride citrate (Drug)
Placebo t.i.d
Placebo Comparator
Placebo of Motireb 5/100 mg t.i.d + Placebo of Mosapride citrate t.i.d
干预措施: Placebo (Drug)
结局指标
主要结局
The responder ratio of GOS(Global Overall Symptom)
时间窗: at the 4th week
次要结局
未报告次要终点
研究者
研究点 (1)
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