NCT02906683已完成2 期
A Phase IIa 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
- 256
- 试验地点
- 1
- 主要终点
- Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8
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 for 8 weeks in female patients with stress urinary incontinence (SUI) compared with placebo as measured by the percent change in incontinence episode frequency (IEF) from baseline.
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 79 Years（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
- •Patient has at least 1 incontinence episodes per day, and urinary diurnal frequency of 10 or less per day and nocturia of 2 or less per day.
- •Patient is positive in 1-hour pad weight test
排除标准
- •Patient has predominant or primary urge incontinence according to investigator judgment
- •Patient had a prior surgical SUI treatment
- •Patient is diagnosed stageII or more of Pelvic Organ Prolapse
- •Patient has symptoms of Urinary tract infection (UTI)
- •Patient is positive pregnancy test
- •Patient has on physical examination, neurological and/or vaginal examination results which, in the opinion of the investigator, should exclude the subject.
研究组 & 干预措施
TAS-303 3mg
Experimental
干预措施: TAS-303 (Drug)
TAS-303 6mg
Experimental
干预措施: TAS-303 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8
时间窗: Baseline to Week 8 (8 weeks in treatment period)
Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 8
时间窗: Baseline to Week 8 (8 weeks in treatment period)
次要结局
- Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 4(Baseline to Week 4 (4 weeks in treatment period))
- Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 4(Baseline to Week 4 (4 weeks in treatment period))
- Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 4 in SUI Subgroup(Baseline to Week 4 (4 weeks in treatment period))
- Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 4 in SUI Subgroup(Baseline to Week 4 (4 weeks in treatment period))
- Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8 in SUI Subgroup(Baseline to Week 8 (8 weeks in treatment period))
- Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 8 in SUI Subgroup(Baseline to Week 8 (8 weeks in treatment period))
- Percentages of the Patients With an Incontinence Amount of ≤ 2.0 g (Deemed Dryness) in the 1-hour Pad Test at Week 8 in the Treatment Period(At Week 8 in the treatment period)
- Patient Global Impression-Improvement (PGI-I) Rates at Baseline, Week 4 and Week 8(Baseline to Week 8 (8 weeks in treatment period))
- Any Adverse Events(Baseline to Week 8 (8 weeks in treatment period))
- Advese Events Occurring in ≥2% of Patients in Any Treatment Group During the Treatment Period(Baseline to Week 8 (8 weeks in treatment period))
- Adverse Drug Reactions(Baseline to Week 8 (8 weeks in treatment period))
- Serious Adverse Events(Baseline to Week 8 (8 weeks in treatment period))
- Adverse Events Leading to Discontinuation of Administration(Baseline to Week 8 (8 weeks in treatment period))
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A Phase 2 Study of TAS-303 in Female Patients With Stress Urinary IncontinenceStress Urinary IncontinenceNCT04512053Taiho Pharmaceutical Co., Ltd.231
已完成
1 期
A Study of TAS-303 in Female Patients With Stress Urinary IncontinenceStress Urinary IncontinenceNCT02562807Taiho Pharmaceutical Co., Ltd.16
已完成
3 期
Efficacy and Safety of Pazopanib Monotherapy After First Line Chemotherapy in Ovarian, Fallopian Tube, or Primary Peritoneal CancerOvarian CancerNCT00866697Novartis Pharmaceuticals940
终止
2 期
Trisenox® in Women With Metastatic Endometrial CancerEndometrial CarcinomaNCT01184053UNC Lineberger Comprehensive Cancer Center3
已完成
3 期
Clinical Trial in Females With Female Pattern Hair LossAlopeciaNCT01145625Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.322