NCT00190814已完成3 期
Efficacy and Safety of Duloxetine Compared With Placebo in Women With Symptoms of Mixed 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
- 600
- 试验地点
- 4
- 主要终点
- The study purpose is to assess the efficacy of duloxetine 40 mg BID for up to 8 weeks in women with mixed urinary incontinence(MUI) compared with placebo as measured by: the change in total incontinence episode frequency(IEF) from baseline to endpoint.
研究概览
简要总结
The purpose of the study is to evaluate the effectiveness of duloxetine in reducing urinary incontinence(leakage of urine)occurrences in women due to physical stress and leakage that occurs during a strong need(urge) to urinate.
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 greater than or equal to 18 years of age.
- •experience episodes of urinary incontinence based on diagnostic criteria of at least 4 episodes a week with symptoms for a minimum of three months prior to start of study.
- •have an educational level and degree of understanding English.
- •are free of urinary tract infections.
- •have a discreet episodes of incontinence(i.e. dry between episodes and do not continuously leak.)
排除标准
- •have received treatment for incontinence within the last 5 years.
- •suffer from severe constipation.
- •currently nursing or breast feeding.
- •any nervous system disease that would affect normal urinary function.
- •any extension of internal organs beyond the vaginal opening.
结局指标
主要结局
The study purpose is to assess the efficacy of duloxetine 40 mg BID for up to 8 weeks in women with mixed urinary incontinence(MUI) compared with placebo as measured by: the change in total incontinence episode frequency(IEF) from baseline to endpoint.
次要结局
- Additional assessments of incontinence episode frequency using various standardized instruments will be performed.
- To monitor the safety of duloxetine based on clinical laboratory values and the occurrence of treatment-emergent adverse events.
研究者
研究点 (4)
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