NCT00191087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
- 458
- 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
研究概览
简要总结
The purpose of this study is to monitor the long term safety of duloxetine in the treatment of 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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with predominant stress urinary incontinence.
- •7 or more incontinence episodes per week.
排除标准
- •Use of monoamine inhibitors.
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
次要结局
- To collect data to demonstrate the maintenance of effect of duloxetine as measured by patient Global Impression of Improvement (PGI-I) questionnaire.
研究者
研究点 (2)
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