NCT00650598已完成4 期
A Multicentre, Double-Blind, Double-Dummy, Randomised Study of the Analgesic Efficacy and Safety of Valdecoxib Compared to Diclofenac Sodium in Patients Undergoing Knee Arthroscopy Procedure for 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
- 发起方
- Pfizer
- 入组人数
- 328
- 试验地点
- 1
- 主要终点
- Patient Assessment of Pain - Visual Analogue Scale
研究概览
简要总结
To demonstrate non-inferiority of valdecoxib 20 mg twice daily (BID) (with an initial loading dose of 40 mg followed by a second dose of 20 mg on the first day only) with diclofenac sodium delayed release 75 mg BID in analgesic efficacy, in subjects undergoing knee arthroscopy procedure for anterior cruciate ligament (ACL) reconstruction, when administered for 6 (±1) days.
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
- •Patients who had undergone an uncomplicated ACL reconstruction procedure and were in satisfactory health were included in the study
- •In addition, they needed to have a baseline pain intensity of ≥ 50 mm on the VAS and "moderate to severe" pain on the categorical scale within 8 hours of the completion of the surgical procedure to be included
排除标准
- •Patient was scheduled to undergo any other surgical procedure, along with the orthopedic procedure, that was expected to produce a greater degree of surgical trauma than the orthopedic procedure alone
- •The patient was undergoing bilateral knee arthroscopy
- •The patient used conventional NSAIDs, COX-2 inhibitors, or Tramadol during the 6 hours preceding surgery, during surgery or subsequent to the end of surgery, until randomization
- •The patient received oxaprozin or piroxicam within one week prior to randomization
- •The patient was required to take muscle relaxants, tricyclic antidepressants, tranquilizers, sedatives, hypnotics and neuroleptics, in the post operative period after the patient was randomized into the study
- •The patient had been treated with patient controlled analgesia subsequent to the end of the surgical procedure
研究组 & 干预措施
Arm 1
Active Comparator
干预措施: valdecoxib (Drug)
Arm 2
Active Comparator
干预措施: diclofenac (Drug)
结局指标
主要结局
Patient Assessment of Pain - Visual Analogue Scale
时间窗: Days 1-6
次要结局
- Physical examination(Screening and Day 6)
- Global Evaluation of Study Medication(Days 1-6)
- Consumption of Rescue Medication(Days 1-6)
- Modified Brief Pain Inventory - short form(Days 2-6)
- Adverse events(Days 1-6)
- Vital signs(Screening, Day 1, and Day 6)
- Effect on Pain Medication Questionnaire and Health Resource Utilization(Days 2-6)
研究者
研究点 (1)
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