NCT00633438已完成4 期
A Double-Blind, Placebo-Controlled, Randomized Comparison Study of the Efficacy of Celebrex 400 mg Single Dose Pre and Celebrex 200 mg Post Ambulatory Arthroscopic Knee Surgery for Total Analgesic Use After Surgery
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 个研究点 分布在 1 个国家目标入组 204 人开始时间: 2004年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Total analgesic use (hydrocodone bitartrate 5 mg/acetaminophen 500 mg [HC/APAP]) after surgery
研究概览
简要总结
To compare total analgesic use at 24 hours after arthroscopic knee surgery in celecoxib-treated versus placebo-treated patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria:
- •Diagnosed (or suspected to have) meniscus trauma of the knee requiring ambulatory arthroscopic knee surgery
- •Willing to participate in study for 36 hours and come to follow-up visit 7 days post surgery
排除标准
- •Exclusion criteria:
- •Osteoarthritis, inflammatory arthritis, or previous fracture of index joint
- •Received acetaminophen or low dose narcotic (vicodin/tylox) within 8 hours of surgery
- •Have received oral (4 weeks), intramuscular (2 months), intra-articular (3 months) or soft-tissue (2 months) injections of corticosteroids of the first dose of study medication or intra-artcular injections of hyaluronic acid in the index joint within 9 months of the first dose of study medication
研究组 & 干预措施
B
Placebo Comparator
干预措施: Placebo (Other)
A
Experimental
干预措施: Celecoxib (Drug)
结局指标
主要结局
Total analgesic use (hydrocodone bitartrate 5 mg/acetaminophen 500 mg [HC/APAP]) after surgery
时间窗: 24 hours
次要结局
- Physical exam(Day 7)
- Number and percentage of patients taking HC/APAP after surgery(1, 2, 6, 8, 10, 12, 24, 36 hours)
- Time to analgesic use after surgery(1, 2, 6, 8, 10, 12, 24, 36 hours)
- Patient Assessment of Pain, according to visual analogue scale, after surgery at rest and flexion(1, 2, 6, 8, 10, 12, 24, 36 hours)
- Adverse events(Day 7)
- Vital signs(Day 7)
- Laboratory evaluation(Day 7)
研究者
研究点 (1)
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