NCT01578304已完成4 期
Phase IV Study to Evaluate the Efficacy and Safety Imidafenacin Versus Fesoterodine in Patients With Overactive Bladder
LG Life Sciences1 个研究点 分布在 1 个国家目标入组 207 人开始时间: 2010年12月最近更新:
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
- 入组人数
- 207
- 试验地点
- 1
- 主要终点
- Difference in daily mean urination frequency between the end of treatment period(Week 12) and the end of observation period(Baseline, Week 0)
研究概览
简要总结
To evaluate the efficacy and safety after 12 weeks oral administration of Imidafenacin 0.1mg b.i.d versus Fesoterodine 4mg once daily for the urge incontinence and/or increased urinary frequency associated with urgency as may occur 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
- 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
- •Male and female patients with overactive bladder aged 20 years or more
- •subject who had the continuos symptom for 3 months or more
- •subject prepare a symptom diary and was deemed eligible for the study by the investigator
- •8 times or more of daily mean urination frequency
- •2 times or more of daily mean frequency of a sense of urinary urgency or 2 times or more of urge incontinence frequency
排除标准
- •subjects with clinically significant stress urge incontinence, patients with urinary tract infections or relapsing urinary tract infections who had received treatment more than 4 times in the previous year
- •subjects with diseases prohibiting anti-cholinergics from administration
- •subjects who used an indwelling catheter or intermittent self intubation program, patients who had prostatic hyperplasia, prostatic cancer, bladder cancer,bladder stones, interstitial cystitis as complications
- •subjects who received lower urinary tract surgery within 6 months
- •subjects with a catheter placed or intermittent catheterization
- •subjects who were deemed ineligible for the study by the investigator or sub-investigator, pregnant women, nursing women, and women who are planning pregnancy or have not used proper contraceptives during the study period
- •subjects who are within 1 month after other clinical study was completed
- •subjects having 100mL or more of residual urine
- •subjects who had acute urinary retention history
- •subjects who have been administered Prohibited concomitant medications
研究组 & 干预措施
Imidafenacin
Experimental
干预措施: Imidafenacin (Drug)
Fesoterodine
Active Comparator
干预措施: Fesoterodine (Drug)
结局指标
主要结局
Difference in daily mean urination frequency between the end of treatment period(Week 12) and the end of observation period(Baseline, Week 0)
时间窗: up to 12 weeks
次要结局
- Difference in daily mean Urinary incontinence frequency between each evaluation time(treatment period Week 4, Week 8, Week 12) and the end of observation period(Baseline, week 0)(up to 12 weeks)
- Difference in daily mean urge incontinence frequency between each evaluation time(treatment period Week 4, Week 8, Week 12) and the end of observation period(Baseline, week 0)(up to 12 weeks)
- Difference in daily mean nocturia frequency between each evaluation time(treatment period Week 4, Week 8, Week 12) and the end of observation period(Baseline, week 0)(up to 12 weeks)
- Difference in daily mean urination frequency between each evaluation time(treatment period Week 4, Week 8) and the end of observation period(baselien, week 0)(up to 12 weeks)
- Difference in QoL score between each evaluation time(treatment period Week 4, Week 8, Week 12) and the end of observation period(Baseline, week 0)(up to 12 weeks)
- Adverse events(up to 24 weeks)
- laboratory test(up to 12 weeks)
- vital signs(up to 12 weeks)
- residual urine(up to 12 weeks)
研究者
研究点 (1)
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