NCT00876421已完成2 期
A Randomised, Multi-Centre, Double-Blind, Placebo and Active-Controlled, 5-Way Parallel Group Study to Investigate the Efficacy, Safety and Tolerability of ONO-8539 in Patients With Overactive Bladder
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
- 435
- 主要终点
- Overactive bladder symptoms
研究概览
简要总结
The objective of this study is to investigate efficacy, safety and tolerability of ONO-8539 in patients with overactive bladder.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with medical history of Overactive Bladder symptoms for > 6 months
排除标准
- •Patients who have a history or presence of other significant diseases, which in the opinion of the investigator, might compromise the patient's safety or the evaluation of the study results
研究组 & 干预措施
P
Placebo Comparator
干预措施: Placebo (Drug)
A
Active Comparator
干预措施: Tolterodine (Drug)
E1
Experimental
干预措施: ONO-8539 (Drug)
E2
Experimental
干预措施: ONO-8539 (Drug)
E3
Experimental
干预措施: ONO-8539 (Drug)
结局指标
主要结局
Overactive bladder symptoms
时间窗: 12 weeks
次要结局
- Overactive bladder symptoms (QOL)(12 weeks)
研究者
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