NCT01753830终止不适用
A Multi Center, Randomized, Double Blind, Saline Controlled Study of a Single Injection of Durolane® Versus a Single Injection of Phosphate Buffered Saline (PBS) to Treat Pain Associated With Osteoarthritis of the Knee
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Galderma R&D
- 入组人数
- 75
- 试验地点
- 25
- 主要终点
- Average Change in WOMAC VAS Pain Score From Week 6 to Week 30
研究概览
简要总结
The purpose of the study is to determine whether a single intra-articular injection of Durolane 4.5 mL is superior to a single injection of PBS 4.5 mL for the relief of joint pain in patients with 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
- Double (Participant, 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
- •Body Mass Index (BMI) ≤ 35 kg/m2
- •Symptomatic osteoarthritis (OA) of the knee
- •K L severity grade 1 or 2
- •If bilateral OA, contralateral knee K L severity grade 0 or 1
排除标准
- •Has clinically apparent tense effusion of the index knee
- •Has had surgery on the symptomatic knee within the previous 12 months or arthroscopy in the index knee in the past 3 months
- •Has any painful orthopedic disorders of the back or hip
- •Has a joint disorder other than osteoarthritis in the index knee
结局指标
主要结局
Average Change in WOMAC VAS Pain Score From Week 6 to Week 30
时间窗: Up to 30 weeks
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain score (0-100 mm Visual Analogue Scale (VAS)). Lower score mean less pain.
次要结局
未报告次要终点
研究者
研究点 (25)
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