NCT01274000已完成2 期
Phase II Study of YM060 - Double-blind, Parallel-group Comparative Study in Patients (Female) With Diarrhea-predominant Irritable Bowel Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 409
- 主要终点
- Responder rate of patients reported global assessment of relief of IBS symptoms
研究概览
简要总结
A study to verify the superiority of YM060 (ramosetron) to placebo for female patients with diarrhea-predominant irritable bowel syndrome (D-IBS) and to evaluate its safety.
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 meeting the Rome III Diagnostic Criteria
- •Loose (mushy) or watery stools within the last 3 months
- •Abdominal discomfort and/or pain during their non-menstrual period
排除标准
- •Patients with a history of surgical resection of the stomach, small intestine or large intestine
- •Patients with a history or current diagnosis of inflammatory bowel disease (Crohn's disease or colitis ulcerative)
- •Patients with a history or current diagnosis of colitis ischemic
- •Patients with a current diagnosis of enteritis infectious
- •Patients with a current diagnosis of hyperthyroidism or hypothyroidism
- •Patients who are currently participating in another clinical trial (including a post-marketing clinical study) or those who participated in another clinical trial (including a post-marketing clinical study) within 12 weeks before the study
- •Patients with a history or current diagnosis of malignant tumor
- •Patients with a history of abuse of drugs or alcohol within 1 year or those who are currently abusing them
研究组 & 干预措施
placebo group
Placebo Comparator
干预措施: placebo (Drug)
YM060 low-dose group
Experimental
干预措施: YM060 (Drug)
YM060 middle-dose group
Experimental
干预措施: YM060 (Drug)
YM060 high-dose group
Experimental
干预措施: YM060 (Drug)
结局指标
主要结局
Responder rate of patients reported global assessment of relief of IBS symptoms
时间窗: for 4 weeks
次要结局
- Responder rate of patients reported assessment of relief of abdominal discomfort and/or pain(for 4 weeks)
- Change in weekly average scores of stool form (appearance)(Baseline and for 4 weeks)
- Safety assessed by the incidence of adverse events and abnormal values in lab-tests(for 4 weeks)
- Responder rate of patients reported assessment of improvement of abnormal bowel habits(for 4 weeks)
研究者
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