NCT01505777已完成2 期
Exploratory Clinical Study to Evaluate the Optimal Dosage of Mosapride and Probiotics in Irritable Bowel Syndrome Without Predominant Diarrhea: Double Blinded, Randomized, Placebo Drug Controlled, Parallel Designed, Multi-centered, Phase 2 Study
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2011年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Change from Baseline in patient's overall satisfaction relief over 4 weeks of treatment of IBS symptoms
研究概览
简要总结
The purpose of this study is to Evaluate the Optimal Dosage of Mosapride (Medirac) and Probitics in Irritable Bowel Syndrome Without Predominant Diarrhea.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-75 years who satisfied RomeIII criteria for the diagnosis of IBS
- •Signed informed consent
排除标准
- •evidence of cathartic colon or history laxative abuse
研究组 & 干预措施
Probiotics(Medirac) 10/mosapride 10mg
Experimental
干预措施: Probiotics (Medirac) (Drug)
Probiotics(Medirac) 15/mosapride 10mg
Experimental
干预措施: Probiotics (Medirac) (Drug)
Probiotics(Medirac) 15/mosapride 15mg
Experimental
干预措施: Probiotics (Medirac) (Drug)
Probiotics(Medirac) 30/mosapride 15mg
Experimental
干预措施: Probiotics (Medirac) (Drug)
Probiotics(Medirac) placebo/mosapride placebo
Placebo Comparator
干预措施: Probiotics (Medirac) placebo/mosapride placebo (Drug)
结局指标
主要结局
Change from Baseline in patient's overall satisfaction relief over 4 weeks of treatment of IBS symptoms
时间窗: baseline and 4 week
次要结局
- Change from Baseline in improvment of abdominal discomfort, pain, bloating, stool frequency, stool consistency, straining urgency over 4 weeks of treatment and during each week(4 weeks,6 weeks)(baseline and 4 weeks, 6 weeks)
研究者
研究点 (1)
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