EUCTR2015-005681-37-BE进行中（未招募）1 期
Evaluation of the evolution of imaging markers of cartilage degradation in patients with knee osteoarthritis receiving DROGLICAN®: a Pilot Study - DRIP
BIOIBERICA S.A.0 个研究点目标入组 20 人开始时间: 2016年2月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
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
入选标准
- •Male or female = 40 years of age with BMI = 40
- •Femorotibial knee OA (Uni- or bilateral)
- •o Responding to clinical and radiological criteria of American College of Rheumatology (ACR)
- •o Symptomatic for more than 6 months in the most painful knee
- •o Radiological K&L grade II-III in radiographs from less than 12 months
- •Moderate-to-severe knee pain: knee pain score evaluated on VAS (0-100) = 40 over the last 24 hours at the inclusion visit (the most painful knee is considered)
- •Able to follow the instructions of the study
- •Having signed an informed consent
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Related to the OA pathology
- •Recent trauma (< 1 month) of the knee responsible of the symptomatic knee
- •Concurrent articular disease interfering with the evaluation of OA and/or pain such as articular dysplasia, aspectic osteonecrosis, acromegaly, Paget’s disease, hemophilia, hemochromatosis, chondromatosis, villonodular synovitis of the knee, seronegative spondyloarthropathy, rheumatoid arthritis, gouty arthritis , infectious arthritis, radiculalgia in the lower limbs, arteritis, etc.
- •Radiological K&L grade I or IV
- •Prosthesis in the target knee
- •Related to treatments
- •Analgesics to manage OA knee pain (Paracetamol, oral NSAIDs, etc.) 24h before inclusion and any follow-up visits
- •Corticosteroids injection in the target knee in the month preceding inclusion
- •Hyaluronan injection in the target knee in the last 6 months
- •Oral corticotherapy = 5mg/day in the last 3 months
- •Symptomatic slow-acting drugs (SYSADs) treatment (Chondroitin, diacerein, glucosamine, soy and avocado unsaponifiables) in the last 3 months
- •An anticipated need for any OA related medication for the duration of the trial (Corticosteroids or hyaluronan injection, Oral corticotherapy, Arthroscopy) which are forbidden during the trial
- •Arthroscopy in the last 6 months
- •Patients with known allergy to CS, GH, or intolerance to rescue treatments (Paracetamol, tramadol and NSAIDs)
- •Patients with allergy to shellfish
- •Related to associated diseases
- •Severe and uncontrolled diseases (liver or renal failure, lung/heart severe disease, tumor, HIV….)
- •Anticipated need for any surgical or other invasive procedure during the trial including prosthesis in the target knee
- •Related to patients
- •Artialis (study coordinator) or Bioiberica (Sponsor) ‘s employees
- •Participation to a therapeutic clinical trial in the last 3 months
- •Under guardianship or judicial protection
- •Pregnancy, breastfeeding, planned conception
- •Women without menopause or tubal ligation and without contraception
- •Related to MRI
- •Unable to receive gadopentetate contrast agent injection because of contraindications:
- •o Acute or chronic severe renal insufficiency (a glomerular filtration rate < 30 mL/min/1.73m2); or
- •o Acute renal insufficiency of any severity due to the hepato-renal syndrome or in the peri-operative liver transplantation period.
- •Known anaphylactic reactions to Gadolinium or related substances
- •Risk groups for MRI scanning due to magnetic field or contrast agent: Metal in body: Pacemaker / AICD / ICD (coronary defibrillator), Nervus vagus stimulator, Artificial heart valve (depending on type), Metal clips on cerebral arteries or veins, Metal particles in eye, Port-a-cath, Metal stents, Hydrocephalic pump / insuline pump, Metal implants; f/e screws, prostheses, piercings.
- •Claustrofibia, or serious mobility problem (Parkinson, tremors)
研究者
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