NCT03452345已完成3 期
A Randomized, Double-blind, Placebo-controlled, Multi-center, Phase 3 Study to Evaluate the Efficacy and Safety of MEDOTIXN® in Subject With Benign Masseteric Hypertrophy
Medy-Tox1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2018年4月9日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- changes in the thickness of the masseter muscle during maximum clenching measured using ultrasound at week 12 from baseline
研究概览
简要总结
To evaluate the efficacy and safety of MEDITOXIN in subjects with benign masseteric hypertrophy compared with 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subject who aged 20 to less than 65 years
- •subject with benign masseteric hypertrophy
排除标准
- •subject not appropriate for participating in this study according to the investigator's opinion
- •subject with known an anaphylactic response to BoNT/A and other involved ingredients of Investigational product
研究组 & 干预措施
MEDITOXIN
Experimental
干预措施: Meditoxin (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
changes in the thickness of the masseter muscle during maximum clenching measured using ultrasound at week 12 from baseline
时间窗: 12 week follow-up visit
次要结局
- changes in the thickness of the masseter muscle as usual measured using ultrasound at week 12 from baseline(12 week follow-up visit)
研究者
研究点 (1)
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