NCT02343978已完成2 期
Phase II, Randomized, Open-label Study of KWA-0711 Administrated Orally for 2 Weeks to Evaluate Its Safety and Efficacy in Patients With Chronic Constipation (CC)
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
- 37
- 主要终点
- Incidence of Adverse Events
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of KWA-0711 in Chronic Constipation (CC) 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
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients who experienced fewer than three Spontaneous Bowel Movements (SBMs) per week for more than 6 months prior to the enrollment
- •The patients who experienced one or more of the following signs or symptoms during more than 25% of bowel movements for more than 6 months: straining, lumpy or hard stools, and a sensation of incomplete evacuation
排除标准
- •Patients who have secondary constipation caused by systemic disorder
- •Patients who have organic constipation
- •Patients who received intestinal resection
研究组 & 干预措施
KWA-0711 High dose
Experimental
干预措施: KWA-0711 (Drug)
KWA-0711 Low dose
Experimental
干预措施: KWA-0711 (Drug)
结局指标
主要结局
Incidence of Adverse Events
时间窗: 2 weeks
次要结局
- Change in fasting and postprandial blood glucose levels(2 weeks)
- Change in fasting and postprandial insulin levels(2 weeks)
- ECGs, vital signs, and clinical labs(2 weeks)
- Improvement of signs and symptoms associated with constipation(2 weeks)
研究者
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