NCT02281630已完成2 期
Phase II, Randomized, Placebo-controlled, Double-blind, Parallel-group Study of KWA-0711 Administered Orally for 4 Weeks to Evaluate Its Efficacy and Safety, and to Determine Its Optimal Dose 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
- 388
- 主要终点
- Change from baseline in the weekly number of Spontaneous Bowel Movements (SBMs) at Week 1
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of KWA-0711, and to determine its optimal dose 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
KWA-0711 High dose
Experimental
干预措施: KWA-0711 (Drug)
KWA-0711 Low dose
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
Change from baseline in the weekly number of Spontaneous Bowel Movements (SBMs) at Week 1
时间窗: 1 week
次要结局
- Complete SBM (CSBM) frequency and responder rate(4 weeks)
- SBM frequency and responder rate(4 weeks)
- Time to first SBM after the initial dose(4 weeks)
- Stool consistency(4 weeks)
- Degree of straining(4 weeks)
- Abdominal bloating and discomfort(4 weeks)
- Use of rescue medications(4 weeks)
- Global assessment of constipation severity(4 weeks)
- Japanese version of IBS-QOL(4 weeks)
- Global assessment of treatment effectiveness(4 weeks)
- Satisfaction rating for the condition of bowel movements(4 weeks)
- Adverse events, ECGs, vital signs, and clinical labs(4 weeks)
研究者
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