NCT00190827已完成3 期
The Effectiveness of Duloxetine Compared With Placebo in the Treatment of Predominant Stress Urinary Incontinence
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 10
- 主要终点
- Evaluate the effects of different regimens of dose escalation and tapering effects on incidence of most prevalent adverse events.
研究概览
简要总结
The study evaluates the effectiveness of duloxetine in reducing urinary incontinence occurrences in women due to physical stress(e.g. stomach pressure on bladder). Incontinence is the inability to control bladder function with leakage of urine.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female outpatients > or = 18 years of age
- •experience episodes of stress urinary incontinence
- •must have an educational level and degree of understanding English
- •are free of urinary tract infections
- •can use the toilet independently
排除标准
- •any in or outpatient surgery in the last six months
- •suffer from severe constipation
- •extension of any internal organs beyond vaginal opening
- •currently breastfeeding
- •any nervous diseases affecting normal urinary function
结局指标
主要结局
Evaluate the effects of different regimens of dose escalation and tapering effects on incidence of most prevalent adverse events.
Compare duloxetine 40 mg BID with placebo in the reduction of incontinence episode frequency(IEF). Study visits occur every two weeks in therapy phase.
次要结局
- Reduction of IEFs using standardized instruments.
- Assessment of overall patient safety.
研究者
研究点 (10)
Loading locations...
相似试验
已完成
3 期
Effectiveness and Safety of Duloxetine in Women Experiencing Urinary Leakage Due to Physical Stress and Urge.Urinary Incontinence, StressNCT00190814Eli Lilly and Company600
已完成
3 期
Evaluate Safety and Efficacy of Duloxetine in Predominant Stress Urinary IncontinenceUrinary Incontinence, StressNCT00190996Eli Lilly and Company2,765
已完成
3 期
Efficacy and Safety of DuloxetineUrinary Stress IncontinenceNCT00190619Eli Lilly and Company100
已完成
2 期
Biomechanical Effects of Duloxetine on Bladder and Sphincter Muscle Function in Women in Pure Genuine Stress IncontinenceUrinary Stress IncontinenceNCT00190567Eli Lilly and Company50
终止
4 期
Duloxetine for the Treatment of Chronic Pelvic PainPelvis Pain ChronicNCT01451606University of Maryland, Baltimore34