NCT00578097终止2 期
A Phase II, International, Multi-centre, Prospective, Randomised, Parallel-group, Double-blind, Dose-ranging, Placebo-controlled, 12-week, Princeps Study to Assess the Efficacy and Safety of a One Injection Cycle With Either Botulinum Toxin Type-A (Dysport® 125, 250 or 500 Units) or Placebo Followed by an Optional 6-month Extension Phase in the Symptomatic Treatment of Micturition Urgency and Frequency in Continent Female Subjects Suffering From Idiopathic Overactive Bladder.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Ipsen
- 入组人数
- 81
- 试验地点
- 31
- 主要终点
- Number of episodes of urgency and frequency of micturition.
研究概览
简要总结
The purpose of this study is to determine the optimal dose of botulinum toxin type A injected in the detrusor muscle to improve urinary symptoms, urodynamic parameters and quality of life of continent women suffering from idiopathic 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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The subject has a diagnosis of idiopathic overactive bladder, without incontinence.
- •The subject has ≥ 3 urgency episodes over the course of the 3 days immediately preceding the Baseline visit.
- •The subject has ≥ 24 episodes of micturition over the course of the 3 days immediately preceding the Baseline visit.
排除标准
- •Bladder outlet obstruction (on urodynamic assessment).
- •Post-Micturition Residual Volume > 150 ml (ultrasound assessment).
- •Evidence of a urinary tract infection at Screening or Baseline in the study.
- •Active or history of interstitial cystitis, malignancy of the bladder or urothelial tract, a carcinoma in situ (non malignant melanoma is allowed) bladder and/or kidney stones.
研究组 & 干预措施
A - 125 units
Experimental
干预措施: Botulinum toxin type A (Biological)
B - 250 units
Experimental
干预措施: Botulinum toxin type A (Biological)
C - 500 units
Experimental
干预措施: Botulinum toxin type A (Biological)
D
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of episodes of urgency and frequency of micturition.
时间窗: Week 12
次要结局
- Safety(All timepoints)
- Extension study - The number of episodes of urgency, frequency of micturition, and frequency of nocturia.(All timepoints)
- Extension study - Duration of effect as determined by the persistence of a positive response.(All timepoints)
- Standard International Continence Society (ICS) urodynamic parameters.(Week 12)
- The number of episodes of urgency, frequency of micturition, and frequency of nocturia.(All timepoints)
- Extension study - Severity of urgency.(All timepoints)
- Quality of Life (QoL).(All timepoints)
- Extension study Quality of Life (QoL)(All timepoints)
- Extension study safety.(All timepoints)
- Maximum flow rate and post-micturition residual volume (PMRV).(Day 4 and Week 6)
- Severity of urgency.(All timepoints)
研究者
研究点 (31)
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