A Long Term Study of YM060 in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 151
- 主要终点
- Change in weekly average of scores of stool form
研究概览
简要总结
To evaluate the efficacy and safety of YM060 once daily for female patients with diarrhea-predominant irritable bowel syndrome (D-IBS) for a long-term period (up to 52 weeks).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Female patients who meet the following criteria:
- •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 who meet any of the following criteria:
- •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
Female Patients with D-IBS
干预措施: YM060 (Drug)
结局指标
主要结局
Change in weekly average of scores of stool form
时间窗: up to 52 weeks
Rate of days without urgency
时间窗: up to 52 weeks
Rate of days without feeling of incomplete bowel movement
时间窗: up to 52 weeks
Monthly responder rate of stool form normalization
时间窗: up to 52 weeks
Monthly responder rate of global assessment of improvement of abnormal bowel habits
时间窗: up to 52 weeks
Monthly responder rate of global assessment of relief of overall IBS symptoms
时间窗: up to 52 weeks
Change in weekly average of stool frequency
时间窗: up to 52 weeks
Monthly responder rate of global assessment of relief of abdominal pain/discomfort
时间窗: up to 52 weeks
Change in entire Japanese version of Irritable Bowel Syndrome Quality of Life (IBS-QOL-J) scores and pairwise IBS-QOL-J scores on the sub-scales
时间窗: 4, 8, 12, 28 and 52 weeks
Change in weekly average of scores of severity of abdominal pain/discomfort
时间窗: up to 52 weeks
次要结局
- Safety assessed through AEs and clinical laboratory values(up to 52 weeks)