跳至主要内容
临床试验/NCT00190996
NCT00190996已完成3 期

The Safety and Effectiveness of Duloxetine Compared With Placebo and Its Long-Term Safety and Efficacy in the Treatment of Predominant Stress Urinary Incontinence

Eli Lilly and Company2 个研究点 分布在 1 个国家目标入组 2,765 人开始时间: 2003年1月最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
2,765
试验地点
2
主要终点
Assess the efficacy of Duloxetine compared with placebo in women with predominant stress urinary incontinence as measured by a reduction in incontinent episode frequency.

研究概览

简要总结

The purposes of this study are to determine whether duloxetine can help subjects with stress urinary incontinence and to see whether the effects of duloxetine can be maintained.

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

入选标准

  • Female diagnosed with stress urinary incontinence

排除标准

  • Currently taking a monoamine oxidase inhibitor

结局指标

主要结局

Assess the efficacy of Duloxetine compared with placebo in women with predominant stress urinary incontinence as measured by a reduction in incontinent episode frequency.

次要结局

  • Evaluate the maintenance of effect on IEF in long-term use
  • Kings Health Questionnaire
  • Patient Global Impression of Improvement Questionnaire
  • Safety effects

研究者

申办方类型
Industry

研究点 (2)

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