Phase III Study of Propiverine Hydrochloride Extended-Release Capsule in the Treatment of Overactive Bladder (OAB) in Chinese Population With Urgent Micturition, Frequent Micturition and/or Urge Urinary Incontinence
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 324
- 试验地点
- 1
- 主要终点
- Alteration of mean micturition frequency within 24h on the basis of continuous 3-day record
研究概览
简要总结
The purpose of this Phase III study is to evaluate the efficacy and safety of Propiverine Hydrochloride Extended-Release Capsule in the treatment of overactive bladder in Chinese population with urgent micturition, frequent micturition and/or urge urinary incontinence.
详细描述
This is a multi-center, randomized, doubled-blind, double dummy clinical study, in comparison with Tolterodine Tartrate Extended-Release Tablet as active parallel control to evaluate the efficacy and safety of Propiverine Hydrochloride Extended-Release Capsule in the treatment of Overactive Bladder in Chinese population with urgent micturition, frequent micturition and/or urge 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 65, male or female patient has a diagnosis of overactive bladder and the symptoms of OAB>3 months subject has urinary frequency (average micturition frequency within 24h>8 times), urgency and/or urge incontinence by micturition diary card during screening period
- •Mean volume of single micturition is less than 200ml by micturition diary dard during screening period
- •The subject is willing and able to complete the micturition diary card correctly
- •Subject's urine routine test show that he/she has no urinary tract infection Subject signs informed consent form
排除标准
- •Confirmed by the investigator that subject has severe stress incontinence.
- •Subject who has serious heart disease or arrhythmia, in the investigator's opinion, is not suitable to enroll.
- •Subject who has contraindications of anticholinergic therapy, such as urinary retention, gastric retention and uncontrollable angle closure glaucoma.
- •Subject who has a symptomatic acute urinary tract infection.
- •Subject who has a recurrent urinary tract infection.
- •Subject who has interstitial cystitis.
- •Subject who has an agnogenic hematuria.
- •Subject who has a bladder outlet obstruction of clinical significance.
- •Subject who needs retention catheterization or intermittent catheterization.
- •Patient with malignant tumor.
- •Subject who has received anticholinergic drugs or other drugs for treating OAB within washout period, or who will receive these drugs after this study begins.
- •Subject who is pregnant or lactating, or plans to be pregnant subject who has received other clinical study drugs or its participating in other clinical trial within 30 days.
- •Women of childbearing age who has not taken sufficient contraception measures within 3 months before random number distribution; or intends to stop the contraception measures during the trial or within one month after the treatment is over.
研究组 & 干预措施
Propiverine Hydrochloride Extended-Release Capsule
30 mg/capsule; oral; once per day
干预措施: Propiverine Hydrochloride (Drug)
Tolterodine Extended-release Tablet
4mg/tablet; oral; once per day
干预措施: Tolterodine Extended-release Tablet (Drug)
结局指标
主要结局
Alteration of mean micturition frequency within 24h on the basis of continuous 3-day record
时间窗: prior to medication and 8 weeks after medication
The voiding frequency per 24 hours, and the alteration of mean micturition frequency within 24 hours on the basis of continuous 3-day record, prior to medication and 8 weeks after medication
次要结局
- The alteration of mean incontinence frequency and mean micturition frequency and volume within 24 hours on the basis of continuous 3-day record(prior to medication, 2 weeks and 8 weeks after medication)