NCT00390260已完成3 期
Randomized, Double-Blind, Placebo-Controlled Trial of the Effect of Rofecoxib 50 mg and Hydrocodone 7.5 mg With Acetaminophen 750 mg in Patients With Postoperative Arthroscopic Pain
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 420
- 主要终点
- Total Pain Relief over 6 hours following a single oral dose compared to placebo.
研究概览
简要总结
Study the effect of rofecoxib 50 mg compared to both placebo, and hydrocodone 7.5 mg with acetaminophen 750 mg, to treat moderate to severe pain following 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective outpatient arthroscopic knee surgery expected to last <= 90 minutes using general anesthesia
- •Patients must experience moderate to severe pain following surgery
- •Patient must be in general good health as judged by the primary investigator
排除标准
- •Osteoarthritis; rheumatoid arthritis
- •Allergy/sensitivity to aspirin, ibuprofen, indomethacin, other NSAIDs, COX-2 inhibitors (e.g., rofecoxib, celecoxib), hydrocodone, acetaminophen
- •Asthma associated with nasal polyps
- •Any arthroscopic knee surgery in the past 6 months
结局指标
主要结局
Total Pain Relief over 6 hours following a single oral dose compared to placebo.
时间窗: 6 hours
次要结局
- Total Pain Relief over 6 hours following a single oral dose compared to hydrocodone + acetaminophen.(6 hours)
研究者
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