NCT04113941Unknown3 期
A Randomized, Double-Blind, Placebo-controlled, Multi-center, Phase 3 Study to Evaluate the Efficacy and Safety of MEDITOXIN® in Subject With Idiopathic Overactive Bladder
Medy-Tox1 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2019年8月23日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- The change in the daily average UI (Urinary Incontinence) episodes
研究概览
简要总结
This study is for patients who have idiopathic overactive bladder symptoms. This study will evaluate efficacy and safety of Neuronox® against placebo.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects aged above 20
- •Patient with overactive bladder symptoms lasting at least 6 months
排除标准
- •Patient with a history of surgery or a disease that may affect bladder function.
研究组 & 干预措施
Neuronox®
Experimental
Neuronox® total 100U, inject 5U/0.5mL per site, 20 sites
干预措施: Neuronox (Drug)
Placebo
Placebo Comparator
Normal saline, same volume with Experimental arm
干预措施: Placebo (Drug)
结局指标
主要结局
The change in the daily average UI (Urinary Incontinence) episodes
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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