NCT00190632已完成3 期
Long-Term Monitoring of Safety in Subjects Treated With Duloxetine for 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
- 600
- 试验地点
- 2
- 主要终点
- To generate long-term safety data for duloxetine in the treatment of women with stress urinary incontinence (SUI)
研究概览
简要总结
This is an on-going study to evaluate the long-term safety and maintenance of effect of duloxetine in patients suffering with stress urinary incontinence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Have had symptoms of SUI for at least 3 months prior to study entry.
- •Have urine leakage most often associated with activity (such as coughing, sneezing, exercise).
- •Ambulatory and able to use a toilet independently and without difficulty.
排除标准
- •Subjects who participated or were discontinued from any previous studies investigating duloxetine.
- •Use of excluded medications within 14 days prior to study entry or at any time during the study.
- •Subjects who currently have or have had a history of urogenital cancer.
结局指标
主要结局
To generate long-term safety data for duloxetine in the treatment of women with stress urinary incontinence (SUI)
次要结局
- To collect data to demonstrate the maintenance of effect of duloxetine as measured by the Patient Global Impression of Improvement (PGI-I) questionnaire.
研究者
研究点 (2)
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