A Multicenter, Randomized, Double Blind, Active Controlled, Parallel Group, Clinical Study, to Evaluate the Safety and Efficacy of Apitox vs Histamine in Subjects With Refractory Osteoarthritis Pain and Inflammation of the Knee
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 363
- 试验地点
- 15
- 主要终点
- WOMAC
研究概览
简要总结
The study will identify the efficacy of Apitox, purified honeybee toxin, in 330 patients with diagnosed osteoarthritis of the knee. The subjects will be evaluated for relief of pain using Western Ontario and McMaster Osteoarthritis Index (WOMAC) and Physician and Patient Global Assessments and primary efficacy measure of relief of pain and inflammation over a 12 week treatment period after randomization into the trial. Secondary efficacy is improvement of mobility Treatment effect will be compared in a 2-1 Apitox vs active control
详细描述
feasibility and Site selection has been completed in the US and India
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 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
Apitox, purified honeybee toxin, injections
active treatment drug 'Apitox, purified honeybee toxin, lyophilized in saline'
干预措施: Apitox, purified honeybee toxin, lyophilized in saline (Biological)
histamine injection
the histamine injection produces a similar local effect of pain and erythema as the active drug
干预措施: histamine (Biological)
结局指标
主要结局
WOMAC
时间窗: from 4 wks dose escalation thru 12 weeks treatment dose to 4 wks follow up
WOMAC
次要结局
- PGA(from 4 wks throught the 12 wk treatment)
- PhGA(from 4 wks global assessment through 12 wks)