NCT01340066已完成1 期
A Randomized, Double-blind, Parallel, Placebo-controlled Study for the Assessment of the Safety and Efficacy of UISH001 for the Symptomatic Improvement of Urinary Incontinence
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 3
- 主要终点
- Percentage of Participants With a Decrease in Leakage Events of 30% or More.
研究概览
简要总结
The purpose of this study is to determine if a new drug treatment is effective for the treatment of symptoms of urinary incontinence.
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 (Participant, Investigator)
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
- •Women who have moderate to severe urge, stress or mixed Urinary Incontinence
排除标准
- •Medical history of migraines, neurologic problems, swallowing disorder, stroke or severe depression.
- •Medical history of heart failure, peripheral edema or moderate to severe asthma or chronic obstructive pulmonary disease (COPD)
- •Certain restricted medications
- •Any other condition that would interfere with the safety of the subject
研究组 & 干预措施
UISH001
Experimental
干预措施: UISH001 (Drug)
Matching placebo
Placebo Comparator
干预措施: matching placebo (Drug)
结局指标
主要结局
Percentage of Participants With a Decrease in Leakage Events of 30% or More.
时间窗: Change from baseline after 4 weeks of treatment.
Incontinence events were recorded on a daily diary. Leaks were scored and tabulated for a daily score. These values were utilized to come up with total of leakage events during the double-blind treatment period.
次要结局
未报告次要终点
研究者
研究点 (3)
Loading locations...
相似试验
已完成
1 期
Safety and Efficacy Study of a New Treatment for Recurrent Symptoms of Oral Herpes Virus InfectionOral Herpes SimplexNCT01308424Beech Tree Labs, Inc.171
已完成
2 期
Safety and Efficacy of MK0594 to Treat Overactive Bladder (0594-003)Urinary IncontinenceOveractive BladderNCT00290563Vyne Therapeutics Inc.557
已完成
2 期
MK0249 for the Symptomatic Treatment of Alzheimer's Disease (MK0249-011)Alzheimer's DiseaseNCT00420420Merck Sharp & Dohme LLC144
终止
2 期
A Study to Evaluate the Efficacy and Safety of CP-101,606 in Subjects With an Acute StrokeStrokeNCT00073476Pfizer300
已完成
2 期
A Study to Evaluate the Clinical Efficacy, Safety and Tolerability of ARX-F03 Sublingual Sufentanil/Triazolam NanoTab™ in Patients Undergoing an Elective Abdominal Liposuction ProcedureSedationPainAnxietyNCT00894699Talphera, Inc40