NCT01600001已完成2 期
A Randomized, Double-blind, Placebo-controlled, Phase II Study of KWA-0711 in Patients With Chronic Idiopathic Constipation (CIC)
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
- 75
- 试验地点
- 1
- 主要终点
- Improvement of signs and symptoms associated with constipation
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of KWA-0711 in Chronic Idiopathic Constipation (CIC) 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
- Double
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 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
Drug:KWA-0711 dose 1
Experimental
干预措施: KWA-0711 (Drug)
Drug:KWA-0711 dose 2
Experimental
干预措施: KWA-0711 (Drug)
Drug:KWA-0711 dose 3
Experimental
干预措施: KWA-0711 (Drug)
Drug:KWA-0711 dose 4
Experimental
干预措施: KWA-0711 (Drug)
Drug: Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Improvement of signs and symptoms associated with constipation
时间窗: 4 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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