NCT00333567已完成4 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Compare Efficacy of a Single Dose of Lumiracoxib 400 mg Given Pre-Emptively Versus Post-Operatively, in Reducing Pain Associated With Ambulatory Arthroscopic Knee Surgery
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Pain Intensity (PI) in the target knee after movement at the 2 h time-point
研究概览
简要总结
This study is designed to investigate the efficacy and safety of a single daily dose of 400 mg lumiracoxib given pre-emptively versus post-operatively in terms of efficacy in reducing pain associated with ambulatory arthroscopic knee surgery
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who need scheduled minor ambulatory arthroscopic knee surgery.
排除标准
- •Patients with any surgical or medical conditions which could place the patient at higher risk from his/her participation in the study, or are likely to prevent the patient from complying with the requirements of the study or completing the trial period.
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Pain Intensity (PI) in the target knee after movement at the 2 h time-point
次要结局
- PI at 1, 2, 3, 4 and 24 h time-points while at rest
- PI at 1, 3, 4 and 24 h time-points after movement
- Time to first rescue medication intake
- Patient's global evaluation of response to study medication
- Safety and tolerability profile
研究者
研究点 (2)
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