NCT00092378已完成3 期
A Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled, Parallel-Group Study of Rofecoxib and Diclofenac Sodium in the Treatment of Post-Bunionectomy Surgery 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
- 251
- 主要终点
- Overall analgesic effect over 8 hours
研究概览
简要总结
This purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of pain following bunionectomy surgery.
详细描述
The duration of treatment is 5 days for rofecoxib and 1 day for diclofenac sodium.
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 (Participant, Investigator)
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
- •Bunion removal
排除标准
- •Any known allergies to the study design
结局指标
主要结局
Overall analgesic effect over 8 hours
次要结局
- Peak analgesic effect on Day 1.
- Overall safety and tolerability.
- The analgesic effect on Days 2-3.
- Time to onset of analgesic effect.
- The use of supplemental analgesia on Days 2-3.
研究者
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