Comparative Study of Efficacy and Safety of Three Intra Articular Injections of V0220 Versus Hyalgan® in Patients Suffering From Symptomatic Knee Osteoarthritis. A Multinational Multicentric, Randomised, Double-blind, Parallel-group Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Pain relief assessed on a global pain Visual Analogic Scale
研究概览
简要总结
The primary objective of this study is to compare a combination of hyaluronic acid and chondroitin sulfate (V0220) to Hyalgan® on pain relief in patients with symptomatic knee osteoarthritis (OA) over 24 weeks when administered in three weekly injections.
Chondroitin sulfate is one of the components of cartilage. Studies have shown that chondroitin sulphate improves the quality of the hyaluronic acid produced in the joint. The benefit of V0220 combination is based on two main physicochemical properties, in line with the characteristics of osteoarthritic disease: optimising the rheological behaviour and improving the buffering effect on synovial flow ("outflow buffering").
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •presenting with uni or bilateral medial and/or lateral femorotibial osteoarthritis of the knee evolving for more than 6 months
- •patients taking analgesic medications for at least 3 months prior to randomisation and dissatisfied with their current therapy
排除标准
- •isolated symptomatic femoropatellar osteoarthritis
- •target knee prothesis
- •having undergone an articular lavage, or an arthroscopy or any surgery on the target knee in the 6 months preceding randomisation,
- •target knee osteoarthritis with clinical joint effusion at selection and at randomization
- •body mass index (BMI) greater than or equal to 30,
- •patient having received any corticosteroid treatment by any administration route (other than inhalers, ocular, auricular route) in the month preceding randomisation,
- •patient having received intra-articular steroid injection in the target knee within the month preceding randomisation or patient having received intra-articular hyaluronic acid in the target knee in the 6 months preceding randomisation
研究组 & 干预措施
V0220
干预措施: Chondroitin sulfate and sodium hyaluronate (Device)
Hyaluronan
干预措施: Hyaluronan (Drug)
结局指标
主要结局
Pain relief assessed on a global pain Visual Analogic Scale
时间窗: change from baseline over 24 weeks
次要结局
- Functional improvement (questionnaire)(change from baseline over 24 weeks)
- Patient's and investigator's global assessment of the disease status (Visual Analogic Scale )(change from baseline over 24 weeks)
- Patient's health related quality of life (questionnaire)(over 24 weeks)
- Consumption of analgesic medication (paracetamol and NSAIDs)(number of days and quantity)(over 24 weeks)
- Medico-economic questionnaire(over 24 weeks)
- Occurrence of adverse events(over 24 weeks)