NCT00290563已完成2 期
A Multicenter, Double-Blind, Randomized, Placebo- and Active-Controlled, Parallel-Group, Dose-Ranging Study of MK0594 in Patients With Overactive Bladder
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 557
- 主要终点
- Change in baseline in average daily micturitions as recorded on patient voiding diaries.
研究概览
简要总结
This study is designed to investigate whether a new drug may offer safe and effective treatment for 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with predominantly urge incontinence overactive bladder episodes
- •Patients must meet minimum eligibility requirements (e.g., average number of micturitions/day) based on screening diary cards
排除标准
- •History of Diabetes insipidus, uncontrolled hyperglycemia or hypercalcemia
- •Lower urinary tract symptoms associated with benign prostatic hypertrophy
- •Active or current Urinary Tract Infections (UTIs)
- •Surgery to correct prolapsed uterus or stress incontinence
结局指标
主要结局
Change in baseline in average daily micturitions as recorded on patient voiding diaries.
时间窗: Duration of Trial
Change in baseline in average daily micturitions as recorded on patient voiding diaries.
次要结局
- The incidence of dry mouth.(Duration of Treatment)
- Average daily strong urgency, total incontinence, and Urge UI episodes from voiding diaries.(Duration of Treatment)
- Global assessment of improvement in UI, perception of urgency, and bother of UI symptoms.(Duration of Treatment)
研究者
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