NCT00127270已完成4 期
Using Behavioral Therapy in Combination With Drug-Darifenacin for Symptoms of Overactive Bladder
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 395
- 试验地点
- 65
- 主要终点
- Change from baseline in average number of urinations per patient per day at Week 12
研究概览
简要总结
This study is designed to investigate the efficacy and safety of treatment of overactive bladder with darifenacin administered alone or in conjunction with behavioral modification therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptoms of overactive bladder
- •Capable of independent toileting and completing a micturition diary
- •Able to comprehend English and follow study procedures and instructions
排除标准
- •Post void residual > 100ml/sec
- •Urine flow rate (Qmax) <10ml/sec for males only
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
1
Experimental
Darifenacin
干预措施: Darifenacin (Drug)
2
Other
Darifenacin in combination with Behavioral Modification Programme for Symptoms of Overactive Bladder
干预措施: Darifenacin (Drug)
2
Other
Darifenacin in combination with Behavioral Modification Programme for Symptoms of Overactive Bladder
干预措施: Behavioral therapy (Behavioral)
结局指标
主要结局
Change from baseline in average number of urinations per patient per day at Week 12
次要结局
- Change from baseline in average number of urination episodes per patient per day at Week 2, Week 6
- Change from baseline in average number of urge urinary incontinence episodes, urgency episodes, incontinence pads, and nocturnal urinations per day measured at Weeks 2, 6, 12
- Quality of Life (baseline, Week 6, Week 12)
研究者
研究点 (65)
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