NCT00449696已完成3 期
A Multi-Center, Randomized, Double-Blind, Controlled, Parallel-Group Study of a Single Intra-Articular Injection of Gel-200 With a Single Intra-Articular Injection of Phosphate Buffered Saline (PBS) 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
- 379
- 试验地点
- 2
- 主要终点
- Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) Pain Subscore
研究概览
简要总结
The purpose of this study is to determine if a single intra-articular injection of Gel-200 is superior to a single injection of Phosphate Buffered Saline (PBS) in subjects with symptomatic osteoarthritis of the knee.
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, Investigator, Outcomes Assessor)
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
- •Subjects with a diagnosis of painful, symptomatic tibio-femoral osteoarthritis of the knee (Grade 1-3 on Kellgren - Lawrence (K-L) score).
排除标准
- •Subjects with Grade 4 on K-L score
- •Subjects with inflammatory diseases of the knee other than osteoarthritis such as rheumatoid arthritis
- •Serious systemic diseases
- •Female subjects who are pregnant or lactating
结局指标
主要结局
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) Pain Subscore
时间窗: Baseline and Week 13
Observed WOMAC pain subscore on VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.
次要结局
- Change From Baseline in WOMAC VAS Stiffness Subscore(Baseline and Week 13)
- Change From Baseline in WOMAC VAS Physical Function Subscore(Baseline and Week 13)
- Change From Baseline in WOMAC VAS Total Score(Baseline and Week 13)
- Outcome Measures in Rheumatology Arthritis Clinical Trials (OMERACT)- and the Osteoarthritis Research Society International (OARSI) Response(Weeks 6 to 13)
- Change From Baseline in Short Form - 36 (SF-36)(Baseline and Week 13)
- Change From Baseline in Subject Global Evaluations(Baseline and Week 13)
- Change From Baseline in Physician Global Evaluations(Baseline and Week 13)
- Acetaminophen Consumption(Weeks 9 to 13 (5 weeks))
研究者
研究点 (2)
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