NCT00554346已完成4 期
A Randomized, Double Blind, Placebo-controlled Study to Assess the the Preemptive Benefit of Etoricoxib in Patients Receiving Anterior Cruciate Ligament Reconstruction
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Pain at rest at different timepoint after surgical procedures
研究概览
简要总结
Post surgical pain associated with ligament reconstruction may persist for few days after the surgical procedure. Arcoxia is a new anti-inflammatory and analgesic drug that alleviate pain through oral administration. This study will test the safety and efficacy of Arcoxia in the management of post-operational pain in patients receive the ligament reconstruction 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 16 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women age ranged from 16~35 who have anterior cruciate ligament injury and/or associated injuries are scheduled for ACL reconstruction surgery.
- •Patient agrees to participate into this study and is willing to sign the patient informed consent form.
排除标准
- 未提供
研究组 & 干预措施
1
Active Comparator
Etoricoxib 90mg
干预措施: Arcoxia(etoricoxib 90 mg/tablet) (Drug)
2
Placebo Comparator
placebo
干预措施: Arcoxia(etoricoxib 90 mg/tablet) (Drug)
结局指标
主要结局
Pain at rest at different timepoint after surgical procedures
时间窗: From baseline(preoperation) to 3 days after
次要结局
未报告次要终点
研究者
研究点 (1)
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