NCT01354145已完成3 期
Twenty-four Month Exploratory Study of the Effect of Chondroitin Sulphate on Structural Changes in Knee Osteoarthritis Patients as Assessed by MRI
Bioiberica5 个研究点 分布在 1 个国家目标入组 194 人开始时间: 2011年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 194
- 试验地点
- 5
- 主要终点
- Cartilage Volume Loss of the Lateral Compartment
研究概览
简要总结
The main purpose of this study is to compare the cartilage volume loss at the Baseline visit and after 24 months of treatment in patients treated with CHONDROITIN SULPHATE (CONDROSAN) 1200 mg daily vs. patients treated with CELECOXIB 200 mg daily.
详细描述
To compare long term disease modifiying and symptomatic effects at the Baseline visit and after 24 months of treatment in patients treated with CHONDROITIN SULPHATE 1200 mg daily vs. patients treated with CELECOXIB 200 mg daily.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals of either sex, aged 40 years and more
- •Subjects presenting primary OA of the knee according to ACR criteria with signs of synovitis (warmth, swelling or effusion
- •OA of radiological stages 2 and 3 according to Kellgren-Lawrence;
- •Minimum joint space width ≥2 mm in the medial femorotibial compartment on standing knee X-ray
- •VAS of pain while walking ≥ 40 mm
排除标准
- •Known allergy to CHONDROITIN SULPHATE, hypersensitivity to CELECOXIB, demonstrated allergic-type reactions to sulphonamides, experienced asthma, urticaria or allergic-type reactions after taking sulphonamides, aspirin (acetyl salicylic acid [ASA]), lactose or NSAIDs
- •Active malignancy of any type or history of a malignancy within the last five years other than basal cell carcinoma
- •Increased risk for prostate cancer, with prostate cancer, or with a history of prostate cancer within the last five years
- •Subjects with other bone and articular diseases (antecedents and/or current signs) such as chondrocalcinosis, Paget's disease of the ipsilateral limb to the target knee, rheumatoid arthritis, aseptic osteonecrosis, gout, septic arthritis, ochronosis, acromegaly, haemochromatosis, Wilson's disease, osteochondromatosis seronegative spondylo-arthropathy, mixed connective tissue disease, collagen vascular disease, psoriasis, inflammatory bowel disease
- •Isolated knee lateral compartment OA defined by joint space loss in the lateral compartment only
- •Class IV functional capacity using the American Rheumatism Association criteria
- •Have had surgery in any lower limb or arthroscopy, aspiration or lavage in any lower limb joint within 180 days of the Baseline Visit
- •History of heart attack or stroke, or experienced serious chest pain related to heart disease, or who have had serious diseases of the heart such as congestive heart failure
- •High risk of CV events, according to the AHA assessment of CV risk tables
- •History of recurrent UGI ulceration or active inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis), a significant coagulation defect, or any other condition, which in the investigator's opinion might preclude the chronic use of CELECOXIB. Subjects may, at the Investigator's discretion, take a PPI or antacids daily as required
- •Have 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
- •Subjects using corticosteroids (oral, injectable; exception of intraarticular/soft tissue injection at the exclusion of the target knee), indomethacin, tramadol, codeine, empracet, therapeutic dose of glucosamine or CHONDROITIN SULPHATE during the 12 weeks preceding inclusion
- •Using hyaluronic acid (intra-articular target knee) during the 26 weeks preceding inclusion
- •Using Natural Health Products (e.g. capsaicin, boswellia, willow bark), and creams and analgesic gels (e.g. camphor and alcohol based gels) during one week preceding baseline;
- •Using Natural Health Products susceptible to increase the risk of bleeding (e.g. garlic, dong quai, etc.) during one week preceding baseline;
- •Receiving radioactive synovectomy (target knee) during the 12 weeks preceding inclusion;
- •Subjects who are receiving NSAID and do not want to stop during the study
- •If treatment of osteoporosis (biphosphonates, SERMS, THS) is necessary, it will have to be continued, unmodified, for the entire duration of the study
- •Have used medications with MMP-inhibitory properties (e.g. tetracycline or structurally related compounds) within 28 days prior to the Baseline Visit
- •Are taking lithium carbonate, phenytoin or anticoagulants (with the exception of ASA up to a maximum daily dose of 325 mg)
- •Have received chondrocyte transplants in any lower extremity joint
- •Use oral or topical COXIBs, calcitonin or immunosuppressive drugs
研究组 & 干预措施
Chondroitin sulfate (Condrosan)
Experimental
CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning
干预措施: Chondroitin sulfate (Drug)
Celecoxib
Active Comparator
CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning
干预措施: Celecoxib (Drug)
结局指标
主要结局
Cartilage Volume Loss of the Lateral Compartment
时间窗: 12 months (Day 364) and 24 months (Day 728)
To compare the cartilage volume loss of the lateral compartment (femoral condyle and tibial plateau) at the Baseline visit and after 12 and 24 months of treatment either with CHONDROITIN SULPHATE (CONDROSAN) 1200 mg daily or with CELECOXIB 200 mg daily.
次要结局
- Cartilage Volume in the Medial Compartment(12 months (Day 364) and 24 months (Day 728))
- WOMAC Pain Subscale(Baseline, 12 months (Day 364) and 24 months (Day 728))
- Short Form (SF-36) Health Survey(Baseline, 12 months (Day 364) and 24 months (Day 728))
- Percentage of Participants With Presence of Joint Swelling and Effusion(Baseline, 12 months (Day 364) and 24 months (Day 728))
- Synovial Membrane Thickness(Baseline, 12 months (Day 364) and 24 months (Day 728))
- WOMAC Stiffness Subscale(Baseline, 12 months (Day 364) and 24 months (Day 728))
- Use of Acetaminophen(3 months (Day 91), 6 momnths (Day 182), 12 months (Day 364), 18 monts (Day 546) and 24 months (Day 728))
- Cartilage Volume Loss of the Global Knee(12 months (Day 364) and 24 months (Day 728))
- Synovial Fluid Volume(Baseline, 12 months (Day 364) and 24 months (Day 728))
- Percentage of Participants With the Presence of Extrusion in the Meniscus(Baseline, 12 months (Day 364) and 24 months (Day 728))
- WOMAC Function Subscale(Baseline, 12 months (Day 364) and 24 months (Day 728))
- Bone Marrow Lesions Score(Baseline, 12 months (Day 364) and 24 months (Day 728))
- Visual Analog Scale (VAS)(Baseline, 12 months (Day 364) and 24 months (Day 728))
研究者
研究点 (5)
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