EUCTR2013-001619-62-BE进行中（未招募）不适用
A multicentre, comparative, randomised, double-blind, double-dummy clinical trial on the efficacy and safety of Condrosulf® versus Celebrex® and versus a placebo in the treatment of knee osteoarthritis
IBSA, Institut Biochimique S.A.0 个研究点目标入组 600 人开始时间: 2014年1月16日最近更新:
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相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 600
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
- •Outpatients of either sex, aged = 50 years
- •Patients affected by primary knee osteoarthritis of the medial or lateral femoro-tibial compartment
- •Diagnosis according to the American College of Rheumatology (ACR) criteria
- •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 = 50mm
- •With radiography dated less than six months showing a remaining articular joint space
- •Without such an axial disorder to justify an osteotomy
- •Women taking contraceptive measures if not in menopause
- •Patients able to understand and follow the study protocol
- •Patients who have signed the written informed consent for their participation in the clinical trial
- •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 400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
排除标准
- •With a history of heart attack, ischemic heart disease or cerebrovascular disease (including transient ischemic attack
- •Having or have had peripheral arterial disease or past surgery of peripheral arteries
- •With a history or currently significant coagulation defect or/and blood dyscrasia
- •With high risk of CV events
- •With any acute or chronic infections requiring antimicrobial therapy or serious viral (e.g. hepatitis, HIV positivity) or fungal infections
- •With a history of recurrent or currently GI ulceration or active inflammatory bowel diseases (e.g. Crohn’s disease or ulcerative colitis)
- •Having been diagnosed as having or have been treated for oesophageal, gastric, pyloric channel, or duodenal ulceration within 30 days prior to receiving the first dose of study medication
- •Having severe liver or kidney disease
- •With allergy to Celebrex® or any of the other ingredients of Celebrex®
- •Having had an allergic reaction to sulphonamides
- •Having had, as a result of intake of acetylsalicylic acid or other NSAIDs, asthma, nose polyps, severe nose congestion, or an allergic reaction such as itchy skin rash, swelling of the face, lips, tongue or throat, breathing difficulties or wheezing
- •Presenting lactose intolerance
- •Mild or not symptomatic knee osteoarthritis : < 7 of Lequesne index,
- •or pain on Huskisson’s VAS (Visual Analogic Scale) < 50mm
- •Predominantly femoro-patellar 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 (e.g. 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:
- •NSAIDs in the 5 days preceding the inclusion (wash out period considering 5 half-lives of the drug)
- •hypnotics, muscle relaxants, anxiolytics, if the intake has started less than 8 days before inclusion
- •paracetamol in the 10 hours preceding the inclusion
- •Foreseen physiotherapy, re-education, alternative medicine (mesotherapy, acupuncture) in the next six months (study period)
- •Presenting:
- •serious organic diseases as renal or hepatic insufficiency or blood dyscrasia
- •psychiatric illness hindering the protocol compliance, alcoholism, ongoing or < 1 year drug dependency
- •Pregnant or likely to become it during clinical trial or lactating
- •Having participated in other clinical trials in the month preceding the clinical trial
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