NCT03209362已完成2 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Repeated Intra-Articular Injection of SI-613 in Patients With Osteoarthritis of the Knee
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 20
- 主要终点
- Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscore Over 12 Weeks
研究概览
简要总结
The objective of the study is to evaluate the efficacy and safety of intra-articular injections of SI-613 compared with placebo for knee OA.
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)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provides their written informed consent.
- •Has a diagnosis at the time of screening of OA of the knee according to American College of Rheumatology (ACR) criteria
- •Is willing to switch to using acetaminophen as a rescue medication
排除标准
- •Has a body mass index (BMI) greater than or equal to 40 kg/m2 at screening.
- •Secondary OA
- •Is a female subject who is pregnant or lactating.
- •Is currently hospitalized or has a planned hospitalization during the life of the study.
结局指标
主要结局
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscore Over 12 Weeks
时间窗: Baseline over 12 weeks
Observed VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain. Change in score from baseline over 12 weeks was analyzed using a repeated measures Analysis of Covariance (ANCOVA) model.
次要结局
- Change From Baseline in WOMAC Pain Subscore at Weeks 12 and 26(Baseline, Weeks 12 and 26)
- Change From Baseline in WOMAC Physical Function Subscore at Weeks 12 and 26(Baseline, Weeks 12 and 26)
- Change From Baseline in WOMAC Stiffness Subscore at Weeks 12 and 26(Baseline, Weeks 12 and 26)
- Change From Baseline in WOMAC Total Score at Weeks 12 and 26(Baseline, Weeks 12 and 26)
研究者
研究点 (20)
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