NCT00475358已完成3 期
Efficacy and Safety of Duloxetine Compared With Placebo in Subjects With 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
- 120
- 试验地点
- 2
- 主要终点
- To assess efficacy of duloxetine 80 mg/day for 8 weeks in women with stress urinary incontinence (SUI) compared with placebo as measured by percent change in incontinence episode frequency from baseline.
研究概览
简要总结
Study F1J-MC-SBBT will examine the effect of duloxetine treatment in women with SUI. The inclusion and exclusion criteria of this Phase 3 study will ensure that all subjects have a clinical diagnosis of SUI.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Are greater than 20 years of age.
- •Are female outpatients.
- •Present with SUI based on the disease diagnostic criteria, average at least one incontinent episode per day on the screening diary, and have had symptoms of SUI for a minimum of 3 months prior to study entry.
- •Are women of non-childbearing potential by reason of hysterectomy, other surgery, or natural menopause, or are women of childbearing potential who test negative for pregnancy at the time of enrollment based on a urine pregnancy test and agree to use a medically accepted means of contraception (for example, intrauterine device [IUD], oral or injectable contraceptives, implant, barrier device, sterilization, abstinence, or sex with a vasectomized male partner) for the duration of the study. Women using oral contraceptives or hormone replacement therapy must have a stable dose and regimen for greater than or equal to 3 months prior to entry into the study.
- •Have no language barrier, agree to comply with the requirements of the protocol, and sign a written informed consent document prior to entry into the study.
排除标准
- •Suffer from severe constipation (for example, have impacted rectum at time of physical examination despite recent evacuation).
- •Has a physical examination, neurological and/or vaginal examination results which, in the opinion of the investigator, should exclude the subject.
- •Are on a medication regimen (including diuretics) for which dose and/or frequency has not been stable for at least 12 weeks prior to randomization, or is anticipated to change during the course of the study.
- •Have had any major inpatient surgery within 3 months prior to study entry.
- •Have current diagnosis of any of the following conditions, disorders, or diseases of the genito-urinary tract: Ureteric, bladder, urethral, or rectal fistula
- •Uncorrected congenital abnormality leading to urinary incontinence
- •Detrusor instability or noncompliant bladder
- •Adult enuresis
- •Voiding difficulty (i.e., subject complains of difficulty emptying their bladder).
结局指标
主要结局
To assess efficacy of duloxetine 80 mg/day for 8 weeks in women with stress urinary incontinence (SUI) compared with placebo as measured by percent change in incontinence episode frequency from baseline.
次要结局
- To compare the efficacy of duloxetine with that of placebo as measured by the change in the disease-specific quality of life instrument (I QOL) scores from baseline to endpoint.
- To compare the efficacy of duloxetine with that of placebo in subject perceived improvement in SUI as measured by the Patient's Global Impressions of Improvement (PGI I) questionnaire.
- To compare the safety of duloxetine with that of placebo in the treatment of SUI based on vital signs, laboratory values, and the occurrence of treatment-emergent adverse events (TEAEs).
研究者
研究点 (2)
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