NCT00190645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
- 4
- 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
The patients are being followed in this study to determine the safety of taking the medication Duloxetine for a long period of time. The patients participating in this study suffer from 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
- •Successfully completed the protocol for Study F1J-MC-SBAV.
排除标准
- •Treatment with a drug, not including study medication, that has not received regulatory approval at the time of study entry.
- •Use of excluded medications within 14 days prior to study entry or at any time during the study.
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 Patient Global Impression of Improvement (PGI-I) questionnaire.
研究者
研究点 (4)
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