NCT04512053已完成2 期
A Phase 2, Randomized, Placebo-controlled, Double-blind Study of TAS-303 in Female Patients With Stress Urinary Incontinence
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 231
- 试验地点
- 1
- 主要终点
- The percent change in the average SUI episode frequency per 24 hours
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of TAS-303 in female patients with stress urinary incontinence.
详细描述
The main purpose of this study is to assess the efficacy of TAS-303 in female patients with stress urinary incontinence (SUI) compared with placebo as measured by the percent change in the average SUI episode frequency per 24 hours from baseline at week 12.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient has symptoms of Stress Urinary Incontinence (SUI) for at least 12 weeks prior to study entry
- •Urinary incontinence in the 1-hour pad weight test exceeds 2.0 g
- •The average number of SUI episodes is 1 or more per day
- •The average number of urge urinary incontinence (UUI) episodes is 0.43 or less per day
- •The number of "SUI episodes" exceeds the number of "other episodes"
- •The average number of urinary diurnal frequency is 10 or less per day and the average number of nocturia frequency is 2 or less per day
排除标准
- •Patient has been diagnosed with mixed urinary incontinence (MUI) that is predominantly UUI
- •Patient has treated medication or therapy for SUI within 14 days before prior to study entry
- •Patient is considered to have SUI that would not be expected to improve unless treated with surgical therapy
- •Patient had a history of surgical treatment for urinary incontinence (Trans-obturator tape surgery, Tension-free vaginal tape surgery, etc.)
- •Patient has stage II or more of Pelvic Organ Prolapse (POP), or had a history of POP repair surgery within 180 days before prior to study entry
- •Patient has a serious illness or medical condition
研究组 & 干预措施
TAS-303
Experimental
干预措施: TAS-303 18 mg/day (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
The percent change in the average SUI episode frequency per 24 hours
时间窗: Baseline, week 12
次要结局
- The change in the international Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)(Baseline, week 4, week 8, week 12)
- The change in the incontinence quality of life instrument (I QOL) scores(Baseline, week 4, week 8, week 12)
- The changes in the overactive bladder symptom score (OABSS)(Baseline, week 4, week 8, week 12)
- Incidence of adverse events and side effects(Up to 13 Weeks)
- The average urinary incontinence episode frequency per 24 hours(Baseline, week 4, week 8, week 12)
- The urinary incontinence volume measured in a 24-hour pad test(Baseline, week 12)
- The change in the Patient's Global Impressions of Improvement (PGI I) questionnaire.(Baseline, week 4, week 8, week 12)
研究者
研究点 (1)
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