NCT01934218已完成不适用
A Multi-Center, Randomized, Double-Blind, Phosphate Buffered Saline-Controlled Study to Evaluate Effectiveness and Safety of a Single Intra-Articular Injection of Gel-One® for the Treatment of Osteoarthritis of the Knee With Open-Label Safety Extension
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 814
- 试验地点
- 41
- 主要终点
- Change From Baseline in Visual Analogue Scores (VAS) Following 50-foot Walk Test Through Week 26
研究概览
简要总结
The purpose of this study is to determine whether Gel-One demonstrates a superior effectiveness in osteoarthritis (OA) knee pain compared with phosphate buffered saline (PBS) injections.
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
- Double (Participant, Investigator)
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
- •Have a knee pain
- •Grade 1 to 3 on the Kellgren-Lawrence grading scale
排除标准
- •BMI greater than 35 kg/m2
- •Received an intra-articular hyaluronic acid injection for the treatment of OA of the knee within 6 months prior to screening
- •Had a joint replacement of the target knee
结局指标
主要结局
Change From Baseline in Visual Analogue Scores (VAS) Following 50-foot Walk Test Through Week 26
时间窗: Baseline up to Week26
Observed VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain following 50-foot walk test. Change in score from baseline through week 26 was estimated using a longitudinal model.
次要结局
未报告次要终点
研究者
研究点 (41)
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