NCT02139319已完成1 期
Dose-Escalation of Botulinum Toxin in Subjects With Osteoarthritis of the Knee
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
- Galderma R&D
- 入组人数
- 22
- 主要终点
- Incidence and severity of adverse events
研究概览
简要总结
The purpose of the study is to evaluate the safety and tolerability of the drug product at each dose level.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Osteoarthritis of the knee
- •Fully weight bearing in the index knee with or without the need for assistive/orthopaedic devices
- •Pain score ≥40 mm of the index knee
- •Committing to continue using their assistive/orthopaedic device throughout the study using the same regimen
排除标准
- •Any infection in the index knee or inflammatory skin disease or other inflammatory diseases at the index knee or the anticipated injection site
- •Surgery on the symptomatic knee within the previous 12 months or arthroscopy in the index knee in the past 3 months
- •Any painful orthopaedic disorder of the back or hip which is likely to interfere with the safety or efficacy assessments
- •A joint disorder other than osteoarthritis in the index knee which could potentially interfere with the safety or efficacy assessments
研究组 & 干预措施
Botulinum toxin
Experimental
Single intra-articular injection
干预措施: Botulinum toxin (Drug)
Placebo
Placebo Comparator
Single intra-articular injection
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence and severity of adverse events
时间窗: Up to 6 weeks
次要结局
未报告次要终点
研究者
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