NCT00646880已完成3 期
Double-Blind Crossover Comparative Ambulatory Urodynamic Monitoring (AUM) Study of Tolterodine PR and Propiverine in Korean Patients With Overactive Bladder (OAB)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Parameters of detrusor activity, occurring throughout the duration of comparable AUM
研究概览
简要总结
The purpose of this study is to compare the difference between tolterodine prolonged release (PR) and propiverine in efficacy as assessed by the AUM and to show that tolterodine PR is similar to propiverine with respect to micturition chart variables and safety profile.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Symptoms of urinary urgency
- •Symptoms of urinary frequency (greater than or equal to 8 micturitions per 24 hours) as verified on the patient's micturition chart
- •Symptoms of overactive bladder for greater than or equal to 6 months
排除标准
- •Stress incontinence as determined by the investigator and confirmed for female patients by a cough provocation test
- •An average volume voided of >200 ml per micturition as verified on the micturition chart before randomization
- •Total daily urine volume of >3000 ml as verified on the micturition chart before randomization
研究组 & 干预措施
Propiverine/tolterodine group
Active Comparator
干预措施: propiverine (Drug)
Tolerodine/propiverine group
Active Comparator
干预措施: tolterodine PR (Drug)
结局指标
主要结局
Parameters of detrusor activity, occurring throughout the duration of comparable AUM
时间窗: 28 days
次要结局
- Number of pads used per 24 hours(28 days)
- Urge Incontinence(28 days)
- Number of urgency episodes(28 days)
- Number of micturitions per 24 hours(28 days)
- Volume voided per micturition(28 days)
- Patient's perception of bladder condition(28 days)
- Patient's perception of treatment benefit(28 days)
- Patient's perception of urgency(28 days)
- The occurrences of adverse events and withdrawals and changes in laboratory variables over each 1-week treatment period.(42 days)
研究者
研究点 (1)
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