NCT01870895已完成3 期
A Double-blind, Parallel-group, Comparative Study in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome
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
- 577
- 主要终点
- Monthly responder rate of global assessment of relief of overall IBS symptoms at final point
研究概览
简要总结
To demonstrate the superiority of YM060 to a placebo in global assessment of relief of overall IBS symptoms and stool form normalization, and to evaluate safety in female patients with diarrhea-predominant irritable bowel syndrome (D-IBS).
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 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients satisfying the Rome III Diagnostic Criteria
- •Patients whose ≥25% of stools were loose or watery and <25% of them were hard or lumpy stools
- •Patients who have abdominal pain or discomfort
- •Patients in whom after occurrence of IBS symptoms the following tests were conducted and in whom no organic changes were observed Pancolonoscopy or contrast enema
排除标准
- •Patients with a history of surgical resection of the stomach, gallbladder, small intestine or large intestine
- •Patients with a history or current evidence of inflammatory bowel disease
- •Patients with a history or current evidence of colitis ischemic
- •Patients with concurrent infectious enteritis
- •Patients with concurrent hyperthyroidism or hypothyroidism
- •Patients with concurrent active peptic ulcer
- •Patients with other concurrent disease that may affect the digestive tract passage or large intestinal function or that is likely to interfere with proper assessment of IBS abdominal pain/discomfort
研究组 & 干预措施
YM060 group
Experimental
干预措施: YM060 (Drug)
Placebo group
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Monthly responder rate of global assessment of relief of overall IBS symptoms at final point
时间窗: Up to 12 weeks
Monthly responder rate of stool form normalization at final point
时间窗: Up to 12 weeks
次要结局
- Monthly responder rate of global assessment of relief of abdominal pain/discomfort(Up to 12 weeks)
- Monthly responder rate of global assessment of improvement of abnormal bowel habits(Up to 12 weeks)
- Change in weekly average scores of severity of abdominal pain/discomfort(Up to 12 weeks)
- Change in weekly average scores of stool form(Up to 12 weeks)
- Safety assessment of YM060(Up to 12 weeks)
研究者
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