NCT01042236已完成2 期
A Phase 2, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled Crossover Study Of The Efficacy Of Fesoterodine In Increasing Urethral Pressure In Stress Urinary Incontinence Patients.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Change From Baseline in Opening Urethral Pressure (OUP) at Day 7
研究概览
简要总结
The hypothesis under evaluation is that fesotorodine may provide clinical benefit in the treatment of the condition of stress urinary incontinence
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, 18 - 65 years
- •SUI symptoms for longer than 3 months
- •Subjects must be non-pregnant and not breastfeeding
排除标准
- •Disease or medical condition affecting the bladder or urinary tract (other tan stress urinary incontinence)
- •Subjects taking medication with effects on the bladder or urinary tract
- •Subejcts with medical conditions which could be adversely affected by administration of fesoterodine - gastrointestinal tract disease, glaucoma, hepatic impairment
研究组 & 干预措施
Arm 1
Experimental
干预措施: Fesoterodine (Drug)
结局指标
主要结局
Change From Baseline in Opening Urethral Pressure (OUP) at Day 7
时间窗: Baseline, Day 7 of each period
OUP measured by urethral reflectometry calculated as the mean of all of the OUP measurements obtained in triplicate at each time point for each participant. Day 7 mean for each treatment period was calculated as the mean of the three measurements taken post-dose on Day 7 of each treatment period separately.
次要结局
- Change From Baseline in Closing Urethral Pressure at Day 7(Baseline, Day 7 of each period)
- Change From Baseline in Opening Urethral Elastance at Day 7(Baseline, Day 7 of each period)
- Change From Baseline in Closing Urethral Elastance at Day 7(Baseline, Day 7 of each period)
- Incontinence Episode Frequency Per 24 Hours(Baseline, Day 7 of each period)
- Percent Change From Baseline in Incontinence Episode Frequency Per 24 Hours(Baseline, Day 7 of each period)
- Stress Incontinence Episode Frequency Per 24 Hours(Baseline, Day 7 of each period)
- Percent Change From Baseline in Stress Incontinence Episode Frequency Per 24 Hours(Baseline, Day 7 of each period)
- Urgency Urinary Incontinence Episode Frequency Per 24 Hours(Baseline, Day 7 of each period)
- Percent Change From Baseline in Urgency Urinary Incontinence Episode Frequency Per 24 Hours(Baseline, Day 7 of each period)
- Plasma 5-hydroxymethyl Tolterodine (5- HMT) Concentration(Baseline, Day 7 of each period)
研究者
研究点 (1)
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