EUCTR2005-005163-29-BE进行中（未招募）不适用
A multicentre, comparative, randomised, double-blind clinical trial on the equivalence of the efficacy and the safety of CHONDROSULF® 1200 mg, oral gel in sachet, once daily, versus CHONDROSULF® 400 mg, capsules, 3 capsules per day, and a placebo in the treatment of knee osteoarthritis.”
IBSA (Institut Biochimique SA)0 个研究点目标入组 336 人开始时间: 2006年2月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 336
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients of either sex, aged = 45 years
- •Patients affected by knee osteoarthritis defined according to Altman’s criteria (ACR), in most cases internal tibio-femoral osteoarthritis, without excluding coeducational forms; in case of a bilateral gonarthrosis, evaluation of the most symptomatic knee, always the same
- •Knee osteoarthritis evolving for more than 6 months
- •Patients suffering from regular pain and functional disorders from at least 3 months
- •Accomplishing a score = 7 of Lequesne index for the knee osteoarthritis
- •Assessing pain on Huskisson’s VAS (Visual Analogic Scale) = 40mm
- •With radiography dated less than one year showing a remaining articular joint space
- •Without such an axial disorder to justify an osteotomy
- •Women taking contraceptive measures if not in menopause
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Insulated or prevalent femoro-patellar osteoarthritis: if attack is linked; inclusion is possible if femoro-patellar attack is only radiological and if the clinical symptomatology is the one of the femoro-tibial osteoarthritis
- •Destructive osteoarthritis of the knee justifying a surgery in the following 6 months
- •Osteoarthritis with hydarthrosis requiring a puncture or an infiltration
- •Important genu varum or valgum > 8° (physiological angle including)
- •Knee joint surgery in the last 3 months (eg. chondroscopy, arthroscopy)
- •Viscosupplementation, tidal lavage in the last 6 months
- •Arthritis and metabolic arthropathies, Paget’s illness
- •Having consumed:
- •- basic treatment of arthritis with SYSADOA (chondroitin sulphates, glucosamine sulphates, diacerrhein, hyaluronic acid) in the last 3 months
- •-treatment with corticoids, by any administration route during the last month
- •-any medication having an influence on pain:
- •?hypnotics, muscle relaxants, anxiolytics, if the intake has started less than 8 days before inclusion
- •?paracetamol in the 10 hours* preceding the inclusion
- •Having experienced physiotherapy, re-education, alternative medicine (mesotherapy, acupuncture) throughout the whole treatment period
- •Presenting a lactose** intolerance
- •_______________________________
- •* Necessary wash out period for the elimination of paracetamol
- •** Placebo's excipient
研究者
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