A Multicenter, Double-blind, Placebo-controlled and Active-reference, Randomized, Parallel, Therapeutic Confirmatory Clinical Study to Evaluate the Efficacy and Safety of DA-8010 in Patients With Overactive Bladder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 607
- 试验地点
- 1
- 主要终点
- Change from baseline in the mean number of micturitions per 24 hours at 12 weeks
研究概览
简要总结
This study will evaluate the efficacy and safety of DA-8010 in patients with overactive bladder for 12 weeks as double-blind, placebo-controlled and active-reference study, and also will evaluate the long-term safety of DA-8010 for 52 weeks in patients with overactive bladder as open-label study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Main Inclusion at Screening (Visit 1):
- •Men and women 19 years or older with OAB symptoms for ≥ 3 months.
- •Subject who is willing and able to complete the voiding diary correctly.
- •Subject who is willing and able to provide informed consent indicating that they understand the purpose and procedures required for the study
排除标准
- •Main Exclusion at Screening (Visit 1):
- •Clinically significant stress urinary incontinence or mixed urinary incontinence where stress is the predominant factor
- •Subject who has Injury or neurodegenerative disease which is able to effect on lower urinary tract and nerves
- •Subject with diabetes insipidus, urinary stone, urinary tract infection, interstitial cystitis, recurrent urinary tract infection, pelvic organ prolapse or neurogenic bladder
- •Clinically significant benign prostatic hyperplasia at the discretion of the investigator
- •Had bladder or lower urinary tract surgery within 12 months from the screening visit
- •Medical history of malignant tumor in urinary system or pelvic organs
- •>150 mL of post-void residual volume in the screening test
研究组 & 干预措施
DA-8010 2.5mg
DA-8010 2.5mg + Solifenacin succinate placebo
干预措施: DA-8010 2.5mg (Drug)
Placebo
DA-8010 placebo + Solifenacin succinate placebo
干预措施: DA-8010 Placebo (Drug)
Placebo
DA-8010 placebo + Solifenacin succinate placebo
干预措施: Solifenacin succinate placebo (Drug)
DA-8010 2.5mg
DA-8010 2.5mg + Solifenacin succinate placebo
干预措施: Solifenacin succinate placebo (Drug)
DA-8010 5mg
DA-8010 5mg + Solifenacin succinate placebo
干预措施: DA-8010 5mg (Drug)
DA-8010 5mg
DA-8010 5mg + Solifenacin succinate placebo
干预措施: Solifenacin succinate placebo (Drug)
Solifenacin 5mg
DA-8010 placebo + Solifenacin succinate 5mg
干预措施: DA-8010 Placebo (Drug)
Solifenacin 5mg
DA-8010 placebo + Solifenacin succinate 5mg
干预措施: Solifenacin 5mg (Drug)
结局指标
主要结局
Change from baseline in the mean number of micturitions per 24 hours at 12 weeks
时间窗: 12 weeks
Change from baseline in the mean number of micturitions per 24 hours at 12 weeks
次要结局
- Change from baseline in the mean number of micturitions per 24 hours at 4 and 8 weeks(4 and 8 weeks)
- Change from baseline in the mean number of urinary urgency(Grade 2, 3, 4) per 24 hours at 4, 8 and 12 weeks(4, 8 and 12 weeks)