NCT00949754已完成2 期
A Multi-Center, Randomized, Double Blind, Active-Controlled, Parallel Group Clinical Study to Evaluate the Dose Effect of Intradermal Injections of Apitox vs. Histamine in Subjects With Osteoarthritis Symptoms of the Knee
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- WOMAC
研究概览
简要总结
The study will evaluate Apitox, pure honeybee venom as a treatment for pain and inflammation of osteoarthritis of the knee.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •osteoarthritis of one or both knees
- •on stable NSAID or none due to intolerance
- •women either post menopausal or on stable birth control
- •no clinically significant disease or or abnormal laboratory values
- •signed informed consent, communicate effectively, understand and comply with all study requirements
排除标准
- •serious or unstable medical or psychological condition
- •known sensitivity to honeybee venom, histamine or lidocaine
- •history of asthma
- •any clinically significant ECG abnormalities
- •any clinically significant laboratory values OOR
- •history of drug or alcohol abuse
- •history of joint injury and forms of inflammatory arthritis
研究组 & 干预措施
histamine
Active Comparator
histamine in saline administered ID as active control for Apitox
干预措施: honeybee venom (Apitoxin (Korea) Apitox (USA)) (Drug)
Apitox pure honeybee venom
Experimental
ID study drug
干预措施: honeybee venom (Apitoxin (Korea) Apitox (USA)) (Drug)
结局指标
主要结局
WOMAC
时间窗: 14 days
次要结局
未报告次要终点
研究者
研究点 (4)
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