NCT01209364已完成3 期
Double-Blind, Randomized, Parallel Group, Multicenter Study of Durolane Compared to Methylprednisolone in Subjects With Osteoarthritis of the Knee
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 442
- 试验地点
- 45
- 主要终点
- Pain level and responder rate
研究概览
简要总结
The primary objective is to determine whether Durolane is non-inferior to methylprednisolone, as assessed by level of pain, when each are given as single intra-articular injections for the relief of pain, in the treatment of symptomatic osteoarthritis of the knee at 12 weeks.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject (female or male) 35-80 years of age
- •Unilateral knee pain
- •Radiographic evidence of OA
- •WOMAC pain score of 7-17
- •Subject normally active
- •Subject has attempted but not responded adequately to previous non-pharmacological therapy(ies);
- •Subject cooperative and able to communicate effectively with the investigators;
- •Body mass index ≤ 40 kg/m2;
- •Signed informed consent obtained.
排除标准
- •Knee effusion
- •Contralateral knee OA
- •Clinically significant joint pain from joints other than the knee
- •Previous intra-articular steroid injection into the study knee within the last 3 months;
- •Previous intra-articular HA injection into the study knee within the last 9 months;
- •Previous allergic type reaction to a HA product, a steroid, or lidocaine/related anesthetics;
- •Treatment with analgesics other than paracetamol (acetaminophen) (including topical agents for the knee) within 5 half lives of the drug prior to the baseline visit;
- •Use of systemic glucocorticosteroids (excluding inhaled steroids) within the last 3 months;
- •Treatment with glucosamine/chondroitin sulfate initiated within the past 3 months
- •Change in physical therapy for the knee within the last three months
- •Arthroscopy or other surgical procedure in the study knee within the past 12 months;
- •Any planned arthroscopy or other surgical procedure during the study period;
- •Previous history or presence of active septic arthritis
- •Active skin disease or infection in the area of the injection site;
- •Systemic active inflammatory condition or infection
- •Bleeding diathesis or use of anticoagulants
- •Current uncontrolled diabetes mellitus;
- •Any medical condition that in the opinion of the investigator makes the subject unsuitable for inclusion
- •Pregnant or breastfeeding woman or woman of childbearing potential not practicing adequate contraception;
- •Involvement in other clinical trials
结局指标
主要结局
Pain level and responder rate
时间窗: up to 12 weeks
次要结局
- Functional assessment(26 weeks blinded phase + 26 weeks OLE)
- WOMAC stiffness score(26 weeks blinded phase + 26 weeks OLE)
- WOMAC physical function(26 weeks blinded phase + 26 weeks OLE)
- Safety assessment (Adverse Events)(26 weeks blinded phase + 26 weeks OLE)
研究者
研究点 (45)
Loading locations...
相似试验
招募中
不适用
Methylprednisolone Versus Dexamethasone in Pediatric Caudal BlockCaudal BlockNCT05717374Mansoura University80
已完成
2 期
Efficacy of Methylprednisolone for Hantavirus Cardiopulmonary SyndromeHantavirus InfectionsNCT00128180University of New Mexico66
招募中
2 期
Methylprednisolone in Patients with Cognitive Deficits in Post-COVID-19 Syndrome (PCS)Post-COVID-19 SyndromeNCT05986422Charite University, Berlin, Germany418
已完成
3 期
Study of COLAL-PRED® in the Treatment of Moderate Acute Ulcerative ColitisUlcerative ColitisNCT00299013Alizyme796
已完成
4 期
99Tc-MDP for Thyroid-Associated OphthalmopathyThyroid-Associated OphthalmopathyNCT03948191Dalian University50