NCT00267215已完成3 期
A One-week Multicenter, Multiple-dose, Randomized, Double-blind, Double-dummy, Parallel-group Comparison of the Analgesic Efficacy and Safety of Lumiracoxib (COX189), Celecoxib, and Placebo in the Treatment of Osteoarthritis of the Knee
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 330
- 试验地点
- 2
- 主要终点
- Assess the short-term (3-5 hours) analgesic efficacy of COX189, 400mg administered once a day for 7 days, compared to placebo and to 200mg celecoxib bid
研究概览
简要总结
This trial assessed the safety and efficacy of a single dose of lumiracoxib 400 mg compared to placebo and to a single dose of celecoxib 200mg. It also assessed safety and efficacy of 400mg lumiracoxib administered once a day for 7 days compared to placebo and to 200 mg celecoxib twice daily.
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
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Osteoarthritis of the knee
- •Pain intensity at baseline of at least 50mm on a 100mm visual analog scale
- •Other protocol-defined inclusion/
排除标准
- 未提供
结局指标
主要结局
Assess the short-term (3-5 hours) analgesic efficacy of COX189, 400mg administered once a day for 7 days, compared to placebo and to 200mg celecoxib bid
次要结局
- Assess the safety and tolerability profile of COX189 in comparison to placebo and celecoxib
研究者
研究点 (2)
Loading locations...
相似试验
已完成
4 期
Efficacy and Safety of Lumiracoxib 400 mg Once Daily in Acute Flares of GoutAcute Gouty ArthritisNCT00170781Novartis234
已完成
4 期
Efficacy of Lumiracoxib in Relieving Moderate to Severe Post-dental Surgery Pain, Compared to Both Placebo and CelecoxibPainNCT00348491Novartis Pharmaceuticals364
已完成
3 期
Efficacy and Safety of Lumiracoxib in Patients With Primary Knee Osteoarthritis (OA)Knee OsteoarthritisNCT00367315Novartis1,684
已完成
4 期
Safety and Efficacy of Lumiracoxib Versus Naproxen in Acute Musculoskeletal PainMusculoskeletal PainNCT00170898Novartis419
已完成
4 期
Efficacy and Safety of Lumiracoxib 400 mg in Arthroscopic Knee SurgeryPainNCT00333567Novartis110