NCT03371342已完成1 期
A Randomized, Double-blind, Active Controlled, Multi-center, Phase 1 Study to Investigate the Safety of MEDITOXIN® in Female Subjects With Idiopathic Overactive Bladder
Medy-Tox1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年12月13日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change from baseline in adverse events of MEDITOXIN at 12 week
研究概览
简要总结
To investigate the safety of MEDITOXIN in female subjects with idiopathic overactive bladder compared with BOTOX
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Female aged more than 20 years
- •Subject who has symptoms of Overactive Bladder for a period of at least 6 months immediately prior to screening
排除标准
- •Patient not appropriate for participating in this study according to the investigator's opinion
研究组 & 干预措施
MEDITOXIN
Experimental
干预措施: Meditoxin (Drug)
BOTOX
Active Comparator
干预措施: Botox (Drug)
结局指标
主要结局
Change from baseline in adverse events of MEDITOXIN at 12 week
时间窗: baseline, week 12 follow up visits
safety profiles
次要结局
- Change from baseline in the daily average number of episodes of urinary incontinence(baseline, week 12 follow up visits)
研究者
研究点 (1)
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