NCT01938196已完成2 期
A Single-blind, Dose-titration Study of KWA-0711 in Patients With Chronic Constipation
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 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 titrated KWA-0711 dose in chronic constipation patients.
研究设计
- 研究类型
- Interventional
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 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 Dose1
Experimental
干预措施: KWA-0711 (Drug)
KWA-0711 Dose2
Experimental
干预措施: KWA-0711 (Drug)
KWA-0711 Dose3
Experimental
干预措施: KWA-0711 (Drug)
KWA-0711 Dose4
Experimental
干预措施: KWA-0711 (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: 5 weeks
* Frequency of Spontaneous Bowel Movements * Bowel Movement Timing * Stool Consistency * Abdominal Assessment * QOL Assessment
次要结局
未报告次要终点
研究者
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