Multicenter, Randomized, Double-Blind, Parallel Controlled Non-Inferiority Clinical Trial Comparing 3 Weekly Intra-articular Injections of SUPARTZ® vs 3 Weekly Intra-articular Injections of Euflexxa® for Treatment of Knee OA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 421
- 试验地点
- 2
- 主要终点
- WOMAC VAS (0:None -100:Extreme) Pain Subscale Score Change From Baseline
研究概览
简要总结
The purpose of this study is to demonstrate non-inferiority of three weekly intra-articular injections of SUPARTZ to three weekly intra-articular injections of Euflexxa for the relief of knee OA.
详细描述
The purpose of this study is to demonstrate non-inferiority of three weekly intra-articular injections of SUPARTZ to three weekly intra-articular injections of Euflexxa for the relief of knee joint pain in subjects with osteoarthritis (OA) of the knee as measured by the VAS (0-100 mm) Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale score Change from Baseline (CFB) over Weeks 3, 6, 12.
Safety will be accessed by recording adverse events, concomitant medications, physical examinations, and vital signs.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical evidence of symptomatic osteoarthritis of the study knee as classified according to Altman criteria.
- •Symptoms in study knee for at least one year prior to the screening visit
- •Verified OA of the study knee of Grade 2 or 3 according to a modification of the grading system of Kellgren-Lawrence (K-L) radiographic severity.
- •Willingness to discontinue NSAIDs (systemic and topical) and non-acetaminophen analgesic use seven days or five half-lives prior to the first injection and throughout the study.
排除标准
- •Inability to perform a 50 foot walk test.
- •Subjects with rheumatoid arthritis, joint infection, other inflammatory and metabolic arthritis, Lupus or dermatologic disorder or skin conditions in close proximity to study knee that would preclude safe intra-articular injections.
- •Prior hyaluronic acid injections into the study knee within six months of the screening visit.
- •Intra-articular or intra-muscular steroid injections within three months of the screening visit or during study participation. Oral corticosteroids within four weeks of the screening visit or during study participation.
- •History of surgical treatment to the study knee or arthroscopic intervention within three months prior to the screening visit.
- •Clinically apparent tense effusion of the study knee on examination determined by either a positive bulge sign or positive ballottement of the patella (patellar tap).
- •Subjects with clinically diagnosed symptomatic OA of the hip.
结局指标
主要结局
WOMAC VAS (0:None -100:Extreme) Pain Subscale Score Change From Baseline
时间窗: Change from Baseline (CFB) over Weeks 3, 6, and 12
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) 0-100mm Pain subscale score Change from Baseline (CFB). Over weeks 3, 6, and 12 least square mean difference in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) (0mm:None - 100mm:Extreme) pain subscale score Change from Baseline (CFB). A single estimate of least squares mean was calculated using data from baseline, weeks 3, 6, and 12.
次要结局
未报告次要终点