NCT00650039已完成3 期
A Multicenter, Double-Blind, Placebo-Controlled, Randomized Study Of The Analgesic Efficacy And Safety Of Valdecoxib 20 Mg QD And Valdecoxib 20 Mg BID Compared To Placebo Over Multiple Days For Management Of Acute Postsurgical Pain In Patients Undergoing Anterior Cruciate Ligament Reconstruction
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 488
- 试验地点
- 1
- 主要终点
- Summed Pain Intensity (categorical) through 24 hours (SPI 24)
研究概览
简要总结
The primary objective was to evaluate the analgesic efficacy of valdecoxib 20 mg daily and valdecoxib 20 mg twice daily compared with placebo in outpatients with moderate-severe pain after arthroscopic anterior cruciate ligament (ACL) reconstruction surgery. Secondary objectives were to compare each valdecoxib dose with placebo on additional measures of pain intensity, health outcomes, the use of rescue medication, and the occurrence of opioid-related symptoms, and to evaluate their safety.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Included patients had uncomplicated arthroscopic ACL reconstruction
- •Subjects were to have a Baseline pain intensity of ≥ 50 mm as measured on a 0 - 100mm visual analogue scale (VAS) and moderate to severe pain on a categorical scale by 23:00 hours on the day of surgery and prior to being discharged from the surgical facility
- •Subjects could not have received any medication or additional procedures that would confound the interpretation of the study results.
排除标准
- •the patient was admitted to or retained in the surgical center/hospital for >23 hours;
- •the patient underwent 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 used conventional nonsteroidal antiinflammatory drugs (NSAIDs), selective cyclooxygenase-2 (COX-2) inhibitors, or tramadol during the 6 hours preceding surgery, during surgery, or subsequent to the end of surgery;
- •the patient received oxaprozin or piroxicam within 1 week prior to randomization;
- •the patient had a pain pump or indwelling catheter during surgery that administered local or intraarticular anesthetics or narcotics at the index joint, or had such an intra-articular injection at the end of surgery;
- •the patient had been treated with patient-controlled analgesia or NSAIDs subsequent to the end of anesthesia;
- •patient had a history of clinically significant GI disease or renal disease, or history of a gastrointestinal ulcer, or cancer, or a laboratory abnormality that would suggest it was not in the subject's best interest to enroll in the trial.
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: valdecoxib (Drug)
Arm 3
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Summed Pain Intensity (categorical) through 24 hours (SPI 24)
时间窗: Day 2 and Day 3
Patient's Global Evaluation of Study Medication (PGESM)
时间窗: Day 2 and Day 3
次要结局
- Patient's Global Evaluation of Study Medication(Day 4 and Day 5)
- Average Pain Intensity (derived from the mBPI-sf) on each study day(Days 2 to 5)
- Worst Pain Intensity (derived from the Modified Brief Pain Inventory Short Form [mBPI-sf]) on each study day(Days 2 to 5)
- Symptom Distress Scale Questionnaire(Days 2 to 5)
- Patient Satisfaction Questionnaire for each study day(Days 2 to 5)
- Time-specific pain intensity (PI) (categorical) on each study day(Days 2 to 5)
- SPI 24 (Visual Analog Scale [VAS]) on each study day(Days 2 to 5)
- Time-specific PI (VAS) on each study day(Days 2 to 5)
- Time to first dose of rescue medication (supplemental analgesia) on each study day(Days 2 to 5)
- Percent of subjects who took rescue medication (supplemental analgesia) on each study day(Days 2 to 5)
- Amount of rescue medication (supplemental analgesia) taken on each study day(Days 2 to 5)
- Individual and Composite Pain Interference With Function score (derived from the mBPI-sf) on each day(Days 2 to 5)
- Time between doses of study medication on each study day(Days 2 to 5)
- Post-Discharge Recovery Experience for each study day(Days 2 to 5)
- SPI 24 (categorical)(Day 4 and Day 5)
研究者
研究点 (1)
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