NCT00450112已完成3 期
A Multi-Center Extension and Open-Label Study of a Single or Repeat Intra-Articular Injection of Gel-200 in Osteoarthritis of the Knee.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 202
- 试验地点
- 2
- 主要终点
- Occurrence of Systemic and Local Adverse Events Following a Single or Repeat Intra-articular Injection of Gel-200
研究概览
简要总结
The purpose of this study is to determine if a single or repeat intra-articular injection of Gel-200 is safe and effective in subjects with symptomatic osteoarthritis of the knee and to determine if original SI-6606/01 Gel-200 therapy is durable beyond the original study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Previous participation in study SI-6606/01.
排除标准
- •Female subjects who are pregnant or lactating.
结局指标
主要结局
Occurrence of Systemic and Local Adverse Events Following a Single or Repeat Intra-articular Injection of Gel-200
时间窗: 13 weeks
次要结局
- Improvement From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) (Pain Subscore)(Baseline and Week 13)
- Improvement From Baseline in WOMAC VAS (Stiffness Subscore)(Baseline and Week 13)
- Improvement From Baseline in WOMAC VAS (Physical Function Subscore)(Baseline and Week 13)
- Improvement From Baseline in WOMAC VAS (Total Score)(Baseline and Week 13)
- Outcome Measures in Rheumatology Artthritis Clinical Trials (OMERACT) - and the Osteoarthritis Research Society International (OARSI) Response(Weeks 13)
- Improvement From Baseline in Subject Global Evaluations(Baseline and Week 13)
- Improvement From Baseline in Physician Global Evaluations(Baseline and Week 13)
- Acetaminophen Consumption(Week 9 to Week 13)
研究者
研究点 (2)
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