NCT00212732已完成3 期
Controlled Study of ONO-8025 (KRP-197) in Patients With Overactive Bladder in Japan
Ono Pharmaceutical Co., Ltd.0 个研究点目标入组 750 人开始时间: 2003年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 750
- 主要终点
- Total number of urinary incontinence episodes per week
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of ONO-8025 (KRP-197) in patients with overactive bladder.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are 20 years old or over with overactive bladder
- •Total number of urinary incontinence episodes per week is 5 or over
- •Mean number of micturition per day is 8 or over
- •Mean number of urinary urgency episodes per day is 1 or over
- •Other inclusion criteria as specified in the study protocol
排除标准
- •Patients with genuine stress incontinence
- •Patients suffering from complications such as bladder tumor, bladder stone and urinary tract infection
- •Patients who have undergone surgical operation of urinary and/or genital organs within 6 months prior to the study
- •Patients suffering from complications for which anticholinergics are contraindicated
- •Other exlcusion criteria as specified in the study protocol
结局指标
主要结局
Total number of urinary incontinence episodes per week
次要结局
- Number of micturition per day, number of urinary urgency episodes per day, volume voided per micturition and QOL
研究者
相似试验
已完成
2 期
Controlled Study of ONO-8025 (KRP-197) in Patients With Overactive Bladder in JapanOveractive BladderNCT00212706Ono Pharmaceutical Co., Ltd.400
已完成
2 期
Study of ONO-8577 in Patients With Overactive BladderOveractive BladderNCT03106623Ono Pharmaceutical Co. Ltd207
已完成
2 期
Study of ONO-8539 in Patients With Overactive BladderOveractive BladderNCT00876421Ono Pharmaceutical Co. Ltd435
已完成
2 期
Controlled Study of ONO-2506PO in Patients With Parkinson's Disease in JapanParkinson's DiseaseNCT00212693Ono Pharmaceutical Co., Ltd.165
已完成
2 期
Placebo-Controlled Study of ONO-2333Ms in Patients With Recurrent Major Depressive DisorderMajor Depressive DisorderNCT00514865Ono Pharma USA Inc278