NCT01288001已完成2 期
A Pilot, Open, Randomised, Controlled, add-on Study Evaluating the Duration of Efficacy of One Intra Articular Injection of Sodium Hyaluronate 2.0% in Patients With Painful Osteoarthritis of the Knee
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- to evaluate the duration of efficacy of one intra articular injection of Ostenil® Plus in patients with painful osteoarthritis of the knee.
研究概览
简要总结
A pilot, open, randomised, controlled, add-on study evaluating the duration of efficacy of one intra articular injection of sodium hyaluronate 2.0% in patients with painful osteoarthritis of the knee
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
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both genders between 40 and 70 years of age;
- •Primary tibiofemoral osteoarthritis of the knee according to American College of Rheumatology criteria;
- •Pain ≥ 4 on a 10 point scale for at least two out of five subscores of the WOMAC Section A at baseline;
- •Radiologically ascertained grade II or III severity knee osteoarthritis on the Kellgren-Lawrence scale;
- •Having given signed informed consent.
排除标准
- •Secondary knee osteoarthritis, including:
- •septic arthritis;
- •inflammatory joint disease;
- •recurrent episodes of pseudogout;
- •Paget's disease of bone;
- •articular fracture;
- •ochronosis;
- •acromegaly;
- •haemochromatosis;
- •Wilson's disease;
- •primary osteochondromatosis.
- •Clinical signs of acute flare (pain, warm, erythema, effusion of signal knee) at baseline;
- •Axial deviation > 15 degrees in valgus or varus on a standing X-ray;
- •Clinically significant medio-lateral or antero-posterior instability;
- •Rapid destructive arthritis, evolving arthritis requiring surgery within the coming year;
- •Significant injury to the signal knee within 6 months prior to baseline;
- •Complete loss of range of motion;
- •Painful knee conditions other than osteoarthritis (e.g., Sudeck's atrophy, intra-articular neoplasm, villonodular synovitis);
- •Necrosis of one of the femur condyles;
- •History or evidence of gout, chondrocalcinosis;
- •Peripheral neuropathy;
- •Concomitant rheumatic disease:
- •fibromyalgia;
- •rheumatoid arthritis;
- •collagen diseases;
- •psoriatic arthritis and other seronegative spondylarthropathies (e.g., ankylosing spondylitis);
- •metabolic and crystal-induced arthropathies;
- •other osteopathies.
- •Contraindications to intra-articular injection according to investigator's judgement (e.g., local infection at injection site, generalised infection with possible bacteraemia);
- •Skin disease in the area of injection;
- •Severe coagulopathy, ongoing anticoagulation therapy;
- •Accompanying OA of the hip of sufficient severity to interfere with the assessment of the signal knee;
- •Disease of spine, hip or other lower extremity joints of sufficient degree to affect assessment of the signal knee;
- •Poor general health interfering with compliance or assessment;
- •Concomitant disease/ailment other than knee OA requiring the regular use of the patient's normal analgesic medicine;
- •Initiation of chronic treatment with antihistaminics, glucocorticoids, antidepressants or tranquilisers, within less than 3 months prior to baseline;
- •Use of assistive devices other than a cane (walking stick);
- •Surgery of the signal knee other than arthroscopy;
- •Arthroscopy of the signal knee within one year prior to baseline;
- •Treatment with symptomatic slow acting drug for OA (SYSADOA, i.e., chondroitin sulfate, diacerein, glucosamine, piascledine), unless the patient has been on a stable dose for at least 4 months prior to baseline;
- •Intra-articular depocorticosteroid injection into the signal knee within 3 months prior to baseline;
- •Intra-articular SH injection into the signal knee within 6 months prior to baseline;
- •Ascertained hypersensitivity to any product used in the study (SH, paracetamol, diclofenac, omeprazole) or to similar compounds;
- •Pregnant or lactating female;
- •Female of childbearing potential without adequate contraceptive methods;
- •Participation in a drug clinical trial within 3 months prior screening;
- •Patients who, in the judgement of the investigator, will not comply with the protocol.
研究组 & 干预措施
Ostenil plus
Experimental
Patient will get Ostenil plus injection and standard treatment of Osteoarthritis
干预措施: Ostenil plus (Drug)
结局指标
主要结局
to evaluate the duration of efficacy of one intra articular injection of Ostenil® Plus in patients with painful osteoarthritis of the knee.
时间窗: 6 months
WOMAC score
次要结局
- to evaluate the effects of the study treatment on pain, joint stiffness, joint function and need for analgesic consumption.(6 months)
研究者
研究点 (1)
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