NCT01357980已完成2 期
A Phase IIa, Multicentre, Double Blind, Single Dose, Parallel Group, Placebo Controlled, Clinical Pilot Study to Assess the Efficacy and Safety of a Single Dose, Intra-Detrusor Injections of 750 Units of Dysport® in Subjects Suffering From Neurogenic Detrusor Overactivity Following Spinal Cord Injury or Multiple Sclerosis.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 47
- 试验地点
- 17
- 主要终点
- Daily Incontinence Episode Frequency (IEF)
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of a single dose of 750 U of Dysport compared to placebo for the improvement in the daily incontinence episode frequency for each administration mode in subjects suffering from neurogenic detrusor overactivity following spinal cord injury or multiple sclerosis.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject, family member or care giver was willing and able to perform clean intermittent catheterisation (CIC) for the duration of the study
- •Inadequate response or refractory to anticholinergic medication
- •Botulinum Toxin naive for intradetrusor injections and with no previous treatment with Botulinum Toxin of any type, within 3 months prior to study entry for any other condition
- •Have a minimum of 2 incontinences per day calculated as the average daily incontinence episode frequency (IEF) over the 3 days preceding the baseline visit
排除标准
- •Significant Baseline renal and/or urinary tract pathology
- •Previous treatment with any endovesical pharmacology agent including detrusor Botulinum Toxin injection
研究组 & 干预措施
Dysport 750 U (15 injection sites)
Experimental
干预措施: Botulinum toxin type A (Biological)
Placebo (15 injection sites)
Placebo Comparator
干预措施: Placebo (Drug)
Dysport 750 U (30 injection sites)
Experimental
干预措施: Botulinum toxin type A (Biological)
Placebo (30 injection sites)
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Daily Incontinence Episode Frequency (IEF)
时间窗: Baseline and Day 84
次要结局
- Urodynamics:Maximum Detrusor Pressure(Baseline, Days 14, 42 and 84)
- Physician's Global Assessment Score of Treatment Response(Day 84)
- Pain Visual Analogue Scale (VAS) Score: During Treatment Injection Procedure(Baseline)
- Urodynamics: Maximum Cystometric Capacity(Baseline, Days 14, 42 and 84)
- Quality of Life (QoL) Total Summary Score(Baseline, 14, 42 and 84)
- Pain Visual Analogue Scale (VAS) Score: Before Treatment Injection(Baseline)
研究者
研究点 (17)
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