NCT01043666已完成3 期
Phase III Study of YM178: A Randomized, Double-blind, Parallel Group, Placebo and Active Controlled, Multi-center Study in Subjects With Symptoms of Overactive Bladder
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,126
- 主要终点
- Change in mean number of micturitions per 24 hrs
研究概览
简要总结
This study is to assess the efficacy and safety of YM178 in patients with symptoms of 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with symptoms of overactive bladder for at least 12 weeks before the study
- •Subjects capable of walking to the lavatory without assistance and measuring the urine volume by him/herself
- •Subject with an average frequency of micturition of 8 or more times per 24-hour period
- •Subject with an average episode of urgency or urge incontinence of one or more times per 24-hours period
- •Subject having provided written informed consent by him/herself
排除标准
- •Subject having stress urinary incontinence as a predominant symptom
- •Subject with transient symptoms suspected for overactive bladder
- •Subject complicated with urinary tract infection, urinary stones, and/or interstitial cystitis or with a historical condition of recurrent urinary tract infection
- •Subject complicated with bladder tumor/prostatic tumor or with the historical condition
- •Subject confirmed to have a post-void residual volume of >=100ml or with a clinically significant lower urinary tract obstructive disease
- •Subject with indwelling catheter or practicing intermittent self-catheterization
- •Subject giving radiotherapy influencing urinary tract functions, or thermotherapy for benign prostatic hyperplasia
- •Subject giving surgical therapy which may influence urinary tract functions within 24 weeks before the study
- •Subject with uncontrolled hypertension (indicated by sitting SBP >=180mmHg or DPB >= 110mmHg)
- •Subject with a pulse rate >= 110bpm or <50 bpm
研究组 & 干预措施
YM178 group
Experimental
oral
干预措施: YM178 (Drug)
placebo group
Placebo Comparator
oral
干预措施: Placebo (Drug)
tolterodine ER group
Experimental
oral
干预措施: tolterodine ER (Drug)
结局指标
主要结局
Change in mean number of micturitions per 24 hrs
时间窗: Within a 12-week treatment period
次要结局
- Change in mean number of urgency episodes per 24 hrs(Within a 12-week treatment period)
- Change in mean number of urge incontinence episodes per 24 hrs(Within a 12-week treatment period)
- Change in mean volume voided per micturition(Within a 12-week treatment period)
- Change in mean number of nocturia episodes(Within a 12-week treatment period)
- Safety assessed by vital signs, adverse events laboratory findings, 12-lead electrocardiogram and post-void residual volume(During 12-week treatment)
- Change in mean number of urinary incontinence episodes per 24 hrs(Within a 12-week treatment period)
研究者
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