A Double-Blind, Double-Dummy, Randomized, Multicenter Study Comparing The Analgesic Efficacy And Safety Of Parecoxib 40mg I.V. To Ketoprofen 100mg I.V. In Renal Colic
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- Mean Pain Intensity Difference at 30 Minutes (mPID30min)
研究概览
简要总结
This is a multicenter, randomized, double blind, double dummy, comparative, active-controlled trial designed to assess the analgesic activity and safety of intravenous doses of parecoxib 40 mg relative to intravenous doses of ketoprofen 100 mg for the treatment of renal colic in outpatients presenting at emergency room settings. This trial is designed to show non-inferiority of parecoxib related to ketoprofen.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patient male or female with a confirmed diagnosis of acute renal colic with moderate to severe pain according to the VAS and Categoric pain scales
排除标准
- •The patient has significant renal or hepatic conditions other than uncomplicated kidney stones.
- •The patient has a history of clinically significant hypersensitivity to any NSAIDs, cyclooxygenase inhibitors, analgesics or sulfa medications which has a cross sensitivity to the medications used in this study.
研究组 & 干预措施
I
Ketoprofen plus placebo parecoxib
干预措施: Ketoprofen 100mg (Drug)
II
Parecoxib plus placebo ketoprofen
干预措施: Parecoxib 40mg (Drug)
结局指标
主要结局
Mean Pain Intensity Difference at 30 Minutes (mPID30min)
时间窗: Minute 30
mPID score was obtained by summation of product of length of the interval and difference in pain intensity (PI) divided by summation of length of the interval. Summation was done from zero to 30 minutes. Difference in pain intensity was obtained by subtracting the Pain Intensity Visual Analogue Scale (PI-VAS) at Minute 30 from baseline PI-VAS score. PI-VAS assessed with response to the question "How much pain are you having right now?" on a 100 millimeter (mm) line, with 0 mm=no pain, 100 mm= worst possible pain. mPID score ranged from -100 to 100. Positive score= improved response in pain.
次要结局
- Number of Participants With Response in Pain Intensity(Minute 30)
- Mean Pain Intensity Difference at 120 Min (mPID120min)(Minute 120)
- Number of Participants With Pain Relief (PR)(Minute 30, 120)
- Patient's Global Evaluation of Study Medication(Minute 30, 120)
- Time-specific Pain Intensity (PI) VAS Score(Baseline, Minute 15, 30, 45, 60, 90, 120)
- Time-specific Pain Intensity Difference (PID) at Minute 15, 30, 45, 60, 90 and 120(Baseline, Minute 15, 30, 45, 60, 90, 120)
- Physician's Global Evaluation of Study Medication(Minute 30, 120)
- Number of Participants With Use of Rescue Medication (RM)(Up to Minute 120)
- Time-weighted Sum of Pain Relief Score Over 120 Min (TOTPAR120min)(Baseline through Minute 120)