ISRCTN91883031已完成4 期

Evaluation of a medical device comprising hyaluronic acid and chondroitin sulfate for intra-articular use in patients suffering from femorotibial osteoarthritis of the knee

Pierre Fabre Research Institute [Institut de Recherche Pierre Fabre] (France)0 个研究点目标入组 30 人开始时间: 2012年4月4日最近更新: 2016年11月7日

适应症

试验速览

暂无简介。

•1. Male or female patients aged between 45 and and 80 years
•2. Suffering from internal and/or external femoro tibial OA:
•2.1. Meeting the criteria of the American College of Rheumatology (ACR)
•2.2. Lasting for at least 6 months
•2.3. Pain > = 40mm as measured on a visual analogue scale (VAS)
•2.4. Stage Kellgren and Lawrence II or III
•3. OA deemed to justify a treatment with intra articular HA according to the investigator
•4. Patient?s written informed consent

•1. Symptomatic femoro-patellar arthrosis or hip arthrosis on the same side, concomitant skeletal disease (Paget disease, rheumatoid arthritis, ankylosing spondylitis)
•2. Former or concomitant treatment (intra-articular corticosteroids, topical or oral NSAIDs, anti-arthritis slow acting treatment, recent surgery)
•3. Individual characteristics incompatible with a drug trial (pregnancy or lack of contraception, serious concomitant disease, participation in a clinical trial within the preceding 30 days)

发起方

Pierre Fabre Research Institute [Institut de Recherche Pierre Fabre] (France)