NCT05829798已完成不适用
An Efficacy and Safety 6-months Study of SYNOLIS VA 80/160 and SYNOLIS VA 40/80 in the Treatment of Symptomatic Knee Osteoarthritis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aptissen SA
- 入组人数
- 82
- 试验地点
- 6
- 主要终点
- Difference in Western Ontario and McMaster Universities Arthritis index (WOMAC) score total between D168 and inclusion visit
研究概览
简要总结
Multicentre, independent assessment study on SYNOLIS VA 80/160 and SYNOLIS VA 40/80 over a period of 24 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient between 35 and 75 years old
- •Patients with knee osteoarthritis. The diagnosis is based on the following American College of Rheumatology (ACR) classification:
- •Knee pain
- •Positive radiography (presence of osteophytes)
- •Morning stiffness < 30 min and/or crepitus while walking
- •Symptoms related to knee osteoarthritis for at least 6 months
- •Treatment failure (i.e. ineffective response) with analgesics and/or NSAIDs or intolerance to NSAIDs or low-grade opioids
- •Kellgren-Lawrence radiographic stage: I - III (pre-inclusion radiography)
- •WOMAC pain index score ≥ 40 mm (VAS 0-100 mm) on the knee to be treated
- •Contralateral knee pain < 10 mm (VAS) compared to treated knee
- •Patient signed inform consent form-
排除标准
- •Inability to understand the study or language used to be informed/sign the consent
- •Participation in another clinical trial within 4 weeks prior to the start of the trial, and commitment to non-participation within 4 weeks following the end of the trial
- •Intraarticular injection of hyaluronic acid in target knee within the 6 months prior to inclusion
- •Patient who has received an intra-articular (IA) or intra-muscular (IM) steroid injection within the 3 months prior to inclusion or has taken oral corticosteroids within the month prior to inclusion
- •Joint, bone, ligament, or any local or loco-regional surgery of the leg involved, arthroscopic operation on the target knee within the 3 months prior to inclusion
- •Any recent trauma to the leg involved, including a sprain, dislocation within the 3 months prior to inclusion
- •Rheumatoid arthritis, joint condition or any other inflammation and arthritis
- •Dermatological disorder or any epidermal conditions that prevent an intraarticular injection
- •Visible joint effusion of the target knee during physical examination evidenced by a protuberance or positive ballottement of the patella
- •Evidence of a subchondral fracture, meniscal lesion, presence of bone or cartilage fragments, horizontal meniscal lesion tear (FLAP) in the target knee
- •Osteonecrosis (1 or both knees)
- •Daily dosage > 101 mg of acetylsalicylic acid as part of cardiovascular preventive treatment (antithrombotic). If dose < 101 mg, must be maintained during the study
- •Known intolerance/hypersensitivity/allergy to any of the components in either product, SYNOLIS VA
- •Fibromyalgia
- •Patient of childbearing potential, pregnant or breast-feeding known at inclusion or in the planning phase during the study unless willing to use contraceptives through the whole duration of the study
- •Excessive and repeated consumption of alcohol or illicit substances
- •Any medical condition that may interfere with the proper conduct of the study (including any surgery or hospitalisation)
结局指标
主要结局
Difference in Western Ontario and McMaster Universities Arthritis index (WOMAC) score total between D168 and inclusion visit
时间窗: 168 days
The Western Ontario and McMaster Universities Arthritis index (WOMAC) is a 24-item, condition-specific questionnaire available in a 5-point Likert and 100 mm visual analog scale (VAS) as well as an 11-box numerical rating scale, composed of three subscales: pain (5 questions), stiffness (2 questions) and physical function (17 questions). VAS was used in this study, with a score of 0 for no pain and 100 mm for the worst pain one can image)
次要结局
- Change in pain measurements, assessed using the Western Ontario and McMaster Universities Arthritis index (WOMAC) pain severity index, as compared to D0(up to 168 days)
- Percentage of subjects using analgesics(up to 168 days)
- Change in the Western Ontario and McMaster Universities Arthritis index (WOMAC) functional severity index, as compared to D0(up to 168 days)
- Change in the Western Ontario and McMaster Universities Arthritis index (WOMAC) stiffness severity index, as compared to D0(up to 168 days)
- Measurement of relief satisfaction by the patient(168 days)
- Measurement of therapeutic efficacy by the investigator (assessor)(168 days)
研究者
研究点 (6)
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