NCT00665574终止不适用
A Prospective, Multi-center, Randomized, Double-blind Feasibility Study to Evaluate the Safety and Performance of ActaVisc and ActaVisc Mx Intra-articular Injection for Management of Pain Associated With Osteoarthritis in the Knee.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Change from Baseline in the WOMAC Pain subscale average score for the treatment knee.
研究概览
简要总结
To evaluate the safety and performance of ActaVisc™ intra-articular injection (ActaVisc) and ActaVisc Mx, for management of pain associated with osteoarthritis in the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics
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, Care Provider, Investigator)
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
- •Osteoarthritis (OA) grade 2 or
- •Symptoms in the treatment knee for at least 12 months.
- •Fully ambulatory patient.
排除标准
- •Secondary OA resulting from rheumatoid arthritis, chondrocalcinosis, osteonecrosis, chronic fibromyalgia or other autoimmune disease.
- •Generalized symptomatic OA in lower extremity joints other than the knees, inflammatory joint disease, bursitis, OA in the hips, or other condition that may interfere with study assessments.
研究组 & 干预措施
1
Experimental
ActaVisc
干预措施: ActaVisc and ActaVisc Mx Intra-articular Injection (Other)
2
Experimental
ActaVisc Mx Intra-articular Injection
干预措施: ActaVisc and ActaVisc Mx Intra-articular Injection (Other)
3
Placebo Comparator
Saline
干预措施: ActaVisc and ActaVisc Mx Intra-articular Injection (Other)
4
Active Comparator
Corticosteroid
干预措施: ActaVisc and ActaVisc Mx Intra-articular Injection (Other)
结局指标
主要结局
Change from Baseline in the WOMAC Pain subscale average score for the treatment knee.
时间窗: 26 weeks post treatment
次要结局
未报告次要终点
研究者
研究点 (2)
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