A Multicenter, Randomized, Double-blind, Parallel, Active-controlled Clinical Trial With Non-inferiority Comparison to Evaluate Efficacy and Safety of Intra-articular Injection of DUROLANE® vs. ARTZ® in Treatment of Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 349
- 试验地点
- 7
- 主要终点
- WOMAC (Western Ontario and McMaster Osteoarthritis Index) Pain Subscale Change From Baseline
研究概览
简要总结
The purpose of this study is to determine the comparative safety and efficacy of intra-articular injection of hyaluronic acid, obtained from two different sources, in the treatment of osteoarthritic pain of the knee.
详细描述
This is a multicenter, randomized, double blind, parallel-controlled clinical trial using a non-inferiority comparison to evaluate the efficacy and safety of an intra-articular injection of Durolane® vs Artz® in the treatment of knee osteoarthritis. Subjects will be randomized 1:1 to receive either Durolane or Artz. All subjects will be followed up for 26 weeks from the initial treatment.The screening period is expected to be up to 2 weeks in duration before the baseline visit. Each subject will provide a written informed consent and undergo a qualifying screening. Assessment at screening will include postero-anterior view of standing weight-bearing semi-flexed radiographs of the study knee. The osteoarthritis changes of the study knee will be graded 0,1,2,3 or 4 according to the Kellgren-Lawrence radiographic scoring criteria. Radiographic assessment will be made by an assigned and well trained investigator at each study center. The study knee and contralateral knee will use the Likert WOMAC 5-point scoring for pain assessment.
Physical examination of the knees and vital signs will be performed (this examination will be repeated at end).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Investigational product was masked from study staff and participants with the exception of the unblinded treating investigator conducting the intra-articular injections.
入排标准
- 年龄范围
- 40 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) 40-80 years of age, inclusive
- •Documented diagnosis of mild to moderate osteoarthritis of the study knee that fulfil the ACR(American College of Rheumatology) criteria
- •Radiographic evidence of osteoarthritis in the study knee (Kellgren Lawrence radiographic score is 2 or 3)
排除标准
- •Clinically apparent tense effusion of the study knee on examination determined by either a positive bulge sign or positive ballottement of the patella
- •Kellgren-Lawrence radiographic score 0, 1 or 4 in the study knee
- •Symptomatic osteoarthritis of the contralateral knee or of either hip that is not responsive to acetaminophen/paracetamol and/or requires any protocol prohibited therapies
研究组 & 干预措施
DUROLANE hyaluronic acid
The investigational product was provided in pre-filled syringes containing stabilized non-animal hyaluronic acid (20 mg/mL). Only one injection was given for those subjects randomized to the DUROLANE group, followed by 4 sham injections. DUROLANE is free from products of animal origin and is manufactured by Q-Med AB Corporation.The sham injection procedure was same as the active injection, except that they were subcutaneous and an empty syringe was used.
干预措施: DUROLANE (Device)
ARTZ sodium hyaluronate
The comparator product, ARTZ, is manufactured by Seikagaku Corporation, Japan. Subjects randomized to the ARTZ group were administered five weekly intra-articular injections (2.5 ml, NASHA 25 mg). ARTZ is a sterile, viscoelastic nonpyrogenic solution of purified, high molecular weight (620,000-1,170,000 daltons) sodium hyaluronate having a pH of 6.8-7.8. The sodium hyaluronate is extracted from chicken combs.
干预措施: ARTZ (Device)
结局指标
主要结局
WOMAC (Western Ontario and McMaster Osteoarthritis Index) Pain Subscale Change From Baseline
时间窗: over 18 weeks (week timepoints 6, 10, 14, and 18)
Pain assessment is made of 5 items; each has 5 possible values 0=none, 1=mild, 2=moderate, 3=severe, 4=extreme. The items are summed for a total range of 0 to 20. Therefore, the pain change from baseline range is -20 to 20. A negative change is a reduction in pain from the baseline pain score. A mixed-effect repeated measures regression model was used to estimate a least square mean for the entire "Measured Time Frame". Change from baseline was the dependent variable. Subject baseline score was a fixed effect covariate. Enrollment site, treatment, visit, and treatment by visit interaction were fixed class effects. Subject was a random effect. A least square mean single point estimate and 95%CI was calculated for the entire "Measured Time Frame" using all data collected at each time point within the "Measured Time Frame".
次要结局
- WOMAC (Western Ontario and McMaster Osteoarthritis Index) Pain Subscale Change From Baseline(over 26 weeks (week 6, 10, 14, 18, and 26))
- WOMAC (Western Ontario and McMaster Osteoarthritis Index) Physical Function Subscale Change From Baseline(over 26 weeks (week timepoints 6, 10, 14, 18, and 26))
- Subject Global Assessment Change From Baseline(over 26 weeks (week timepoints 6, 10, 14, 18, and 26))
- WOMAC (Western Ontario and McMaster Osteoarthritis Index) Knee Stiffness Subscale Change From Baseline(over 26 weeks (week timepoints 6, 10, 14, 18, and 26))
- WOMAC (Western Ontario and McMaster Osteoarthritis Index) Physical Function Subscale Change From Baseline(over 18 weeks (week timepoints 6, 10, 14, and 18))
- Subject Global Assessment Change From Baseline(over 18 weeks (week timepoints 6, 10, 14, and 18))
- WOMAC (Western Ontario and McMaster Osteoarthritis Index) Knee Stiffness Subscale Change From Baseline(over 18 weeks (week timepoints 6, 10, 14, and 18))