NCT00330135终止3 期
Multicentre, Randomized, Placebo-Controlled, Double-Blind Clinical Trial to Investigate the Efficacy of Sodium Hyaluronate in Patients With Symptomatic Hip Osteoarthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 85
- 主要终点
- Change in overall pain, 3 months after a single intra-articular injection. The intensity of the pain will be evaluated using a continuous VAS of 100 mm of the overall level of pain in the affected hip.
研究概览
简要总结
To demonstrate the difference in terms of symptomatic efficacy between ADANT® sodium hyaluronate and placebo following an intra-articular injection in patients with symptomatic osteoarthritis of the hip.
Each patient will receive an injection of sodium hyaluronate or placebo in the symptomatic hip and will be followed up for three months.
At the third month, if the score for overall pain is still > 40 mm on the VAS, a second injection of ADANT® can be given irrespective of which treatment was received previously. The patient will be followed up for a further 3 months in an open-label fashion (monthly visits).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary osteoarthritis of the hip defined according to the ACR criteria; symptomatic,
- •Osteoarthritis of radiological grade II to III according to the Kellgren-Lawrence classification, using X-rays performed during the last three months,
- •Overall pain intensity between 40 and 80 mm on a VAS of 100 mm at the pre-screening examination,
- •The patients experienced pain at least one in two days during the last 30 days, it was resistant to paracetamol treatment at a dose of 4 g/day and a step 2 analgesic or a NSAID taken for at least 10 days,
- •A prosthesis is not planned in the next six months.
排除标准
- •Women who are pregnant or breastfeeding or women who could become pregnant and are not using effective contraception,
- •Major dysplasia (defined using Lequesne's criteria as dislocation of the hip),
- •Treatment by intra-articular injection of hyaluronic acid in the symptomatic hip during the 6 months prior to pre-screening,
- •Patients with a history of hypersensitivity to any of the ingredients in the hyaluronan,
- •The presence of inflammatory arthropathy or another disorder or condition that could affect the joint (e.g., rheumatoid arthritis, metabolic bone disease, femoral head necrosis, psoriasis, gout, infection),
- •Another muscular or skeletal condition that could interfere with the evaluation of the efficacy of the treatment on the hip in question (evaluation of pain or functional handicap),
- •Systemic corticosteroid therapy or intra-articular injection of corticosteroids into the ipsilateral hip or knee within the last month,
- •Intermittent claudication or vascular disease,
- •Previous surgery on the hip in question,
- •Septic arthritis at any site,
- •Any surgical procedure, including arthroplasty or arthroscopy, to the hip during the six months prior to pre-screening or surgery scheduled during the trial,
- •Any chronic skin condition that could affect the site of the injection,
- •Use of the investigational treatment or material during the last three months,
- •Oral or injectable anticoagulant treatment,
- •Antiaggregant platelet treatment, particularly low-dose aspirin,
- •Symptomatic chondrocalcinosis in the painful hip
研究组 & 干预措施
1
Experimental
Sodium hyaluronate 2.5 ml - 1 injection
干预措施: Sodium hyaluronate (Drug)
2
Placebo Comparator
Placebo injection - 1 injection
干预措施: placebo injection (Drug)
结局指标
主要结局
Change in overall pain, 3 months after a single intra-articular injection. The intensity of the pain will be evaluated using a continuous VAS of 100 mm of the overall level of pain in the affected hip.
时间窗: 3 months
次要结局
- Proportion of responding patients and proportion of patients with a symptomatic response (OARSI criterion)(3 months)
- WOMAC index (the 3 subscales)(3 months)
- Consumption of analgesics and NSAIDs(3 months)
- Evaluation of tolerability (AE reporting)(3 months)
研究者
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