NCT02079727已完成3 期
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
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 604
- 试验地点
- 16
- 主要终点
- Pain (VAS in mm)
研究概览
简要总结
The purpose of this study is to confirm the efficacy and safety of 800 mg Chondroitin 4&6 sulfate (Condrosulf) vs placebo once a day for 6 months in the symptomatic treatment of knee osteoarthritis. A third group, Celecoxib 200 mg (Celebrex) once a day, will be used as active comparator.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
- •Kellgren & Lawrence grade I-III
- •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's index for the knee osteoarthritis
- •Assessing pain on Huskisson's VAS ≥ 50 mm
- •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
- •Women having negative pregnancy test
- •Patients able to understand and follow the study protocol
- •Patients who have signed the written informed consent for their participation in the clinical trial
排除标准
- •With a history of heart attack, ischemic heart disease or cerebrovascular disease (including transient ischemic attacks)
- •Having or have had peripheral arterial disease or past surgery orf peripheral arteries
- •With a history or currently significat coagulation defect or/and blood dyscrasia
- •With high risk of cardiovascular 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 gastrointestinal 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's index,
- •Pain on Huskisson's VAS (Visual Analogic Scale) < 50 mm
- •Predominantly femoro-patellar osteoarthritis
- •Destructive osteoarthritis of the knee justifying a surgery in the following 6 months
- •Osteoarthritis with hydrarthrosis requiring a puncture or an infiltration
- •Important genu varum or valgus >8° (physiological angle including)
- •Kellgren & Lawrence grade IV
- •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, symptomatic slow acting drugs for osteoarthrithis (chondroitin sulphates, glucosamine sulphates, diacerhein, hyaluronic acid and food supplement for joint care) in the last 3 months; treatment with corticoids, by any administration route during the last month; any medication having an influence on pain:
- •NSAIDs (nonsteroidal anti-inflammatory drugs) 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 psychiatric illness hindering the protocol complaince, alcoholism, ongoing or < 1 year drug dependency
- •Pregnant or likely to become it during clinical trial or lactating
- •Women having positive pregnancy test
- •Having participated in other clinical trials in the month preceding the clinical trial.
研究组 & 干预措施
Condrosulf (Chondroitin 4&6 sulfate)
Experimental
1 tablet of Condrosulf 800 mg and 1 capsule of placebo of Celebrex once a day for 182 days
干预措施: chondroitin sulfate (Drug)
Placebo (PBO) 800 mg tablet and Placebo (PBO) 200 mg capsule
Placebo Comparator
1 tablet of PBO of Condrosulf and 1 capsule of PBO of Celebrex, once a day for 182 days
干预措施: placebo (Drug)
Celebrex 200 mg capsule
Active Comparator
1 capsule of 200 mg of Celebrex and 1 tablet of 800 mg placebo of Condrosulf once a day for 182 days
干预措施: celecoxib (Drug)
结局指标
主要结局
Pain (VAS in mm)
时间窗: Day 1 and Day 182
Decrease in the VAS (pain in mm) from Day 1 to Day 182
Lequesne's Index
时间窗: Day 1 and Day 182
Decrease in the scores of the Lequesne's Index from Day 1 to Day 182.
次要结局
- Lequesne's Index(Day 1, 30, 90 and 182)
- Pain (VAS in mm)(Day 1, 30, 91 and 182)
- MCII (minimal clinically important improvement)(Day 1, 30, 91 and 182)
- PASS (patient acceptable symptom state)(Day 1, 30, 91 and 182)
- Consumption of Paracetamol(Day 1, 30, 91 and 182)
- Global efficacy assessment(At Day 30, 91 and 182)
- Number of adverse events related to the treatments(At Day 30, 91 and 182)
- Number of drop-outs due to AE (adverse event) related to the treatment(At Day 30, 91 and 182)
研究者
研究点 (16)
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