A Placebo-controlled, Double-blind, Randomized Trial of a Single Intra-articular Delivery of SB-061 for the Treatment of Symptomatic Osteoarthritis of the Knee
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Pain
研究概览
简要总结
This study evaluates a novel agent, SB-061, for the treatment of osteoarthritis of the knee. Half of the patients will receive the agent via intra-articular injection and half will receive a placebo injection.
详细描述
The treatment of pain associated with osteoarthritis may include periodic intra-articular injections of corticosteroids or viscosupplements such as hyaluronic acid. SB-061 is anticipated to relieve osteoarthritis pain by reinforcing the cartilage matrix and providing a lubricating coating of the cartilage. Subjects will receive 1 intra-articular injection of either SB-061 or placebo and be followed for 3 months to evaluate pain amelioration. Subjects and Investigators are blinded to treatment allocation.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Femorotibial osteoarthritis of the knee
- •Radiological OA Kellgren-Lawrence grade 2 or 3
- •WOMAC Pain 1 score of the target knee of ≥4 and ≤ 9
排除标准
- •Hypersensitivity to medications or to intra-articular injections
- •Intra-articular delivery of corticosteroids or hyaluronic acid in the target knee within 6 months of study
- •High dose systemic corticosteroid treatment of longer (>14 days) duration w/in 6 months of study
- •Major surgery or arthroscopy of the target knee within year prior to study
- •Planned surgery in the target knee within the next 3 months
- •Concomitant inflammatory disease affecting either knee
研究组 & 干预措施
Placebo
Placebo
干预措施: Placebo (Other)
SB-061
SB-061
干预措施: SB-061 (Device)
结局指标
主要结局
Pain
时间窗: Baseline, 4 weeks
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain (A1) scores from baseline to 4 weeks post treatment will be compared between treatment and control groups.
Incidence of Treatment-Emergent Adverse Events
时间窗: Through 4 weeks
A summary of Treatment-Emergent Adverse Events will be reported
次要结局
- Physical function(Baseline, 4 weeks)
- Pain(Baseline, 4 weeks)