NCT01458197已完成2 期
A Prospective, Multi-center, Placebo-controlled, Randomized, Double-blind, Phase 2 Study to Compare the Efficacy and Tolerability of Tarafenacin 0.2 mg and Tarafenacin 0.4 mg to Placebo Administered as Oral Daily Dose for Three Months in Patients Suffering From 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
- 235
- 试验地点
- 1
- 主要终点
- the change in the number of micturitions per 24 hours from baseline to the end of the 12 weeks treatment period
研究概览
简要总结
- Primary Objective:
To evaluate the dose-response relationship of tarafenacin on efficacy. 2. Secondary Objectives:
- To compare 12 weeks' efficacy of different doses of tarafenacin to that of placebo in patients suffering from Overactive Bladder. .
- To compare the tolerability of different doses of tarafenacin to that of placebo in patients suffering from 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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Tarafenacin 0.2 mg
Experimental
Group 1
干预措施: Tarafenacin 0.2 mg (Drug)
Tarafenacin 0.4 mg
Experimental
Group 2
干预措施: Tarafenacin 0.4 mg (Drug)
Placebo
Placebo Comparator
Group 3
干预措施: Placebo (Drug)
结局指标
主要结局
the change in the number of micturitions per 24 hours from baseline to the end of the 12 weeks treatment period
时间窗: 12 weeks
次要结局
- Mean change from baseline to 12weeks in Number of urgency episodes(12 weeks)
- Mean change from baseline to 12weeks in Number of incontinence episodes(12 weeks)
- Mean change from baseline to 12weeks in Number of nocturia episodes(12weeks)
- Mean change from baseline to 12weeks in Volume of urine passed per void(12weeks)
- Mean change from baseline to 12weeks in score of King's Health Questionnaire(12weeks)
研究者
研究点 (1)
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