NCT00346268终止4 期
Randomized, Double-Blind Study Of The Morphine-Sparing Efficacy And Safety Of Parecoxib Sodium 40 Mg IV Followed By 20 Mg IV Every 12 Hours In The Treatment Of Pain Following Radical Prostatectomy
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Cumulative Amount of Morphine Administered in the First 24 Hours Following Surgery
研究概览
简要总结
The primary objective of this study is to demonstrate the opioid-sparing efficacy of parecoxib 40 mg intravenously given as a loading dose followed by 20 mg intravenously in the 24 hours after the end of surgery.
详细描述
The study was terminated due to lack of recruitment due to competing alternative operation methods on 13September 2010. The decision to terminate the trial was not based on any safety concerns.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •The patient's ASA physical status is 1 or 2 and he has a low risk (i.e.,<10%) of developing an acute coronary event within the next 10 years according to the PROCAM risk assessment calculator.
- •The patient is scheduled to undergo routine radical prostatectomy performed under a standardized regimen of general anesthesia, and is expected to experience moderate to severe postsurgical pain in the absence of postoperative analgesia.
排除标准
- •The patient has a history of uncontrolled chronic disease or a concurrent clinically significant illness or medical condition such as a diagnosed chronic pain condition, which, in the Investigator's opinion, would contraindicate study participation or confound interpretation of the results
- •The patient has a history or current presence of congestive heart failure (NYHA II-IV), established ischaemic heart disease, peripheral arterial disease and / or cerebrovascular disease.
研究组 & 干预措施
Morphine plus Parecoxib
Active Comparator
干预措施: Morphine, Parecoxib (Drug)
Morphine and Placebo
Active Comparator
干预措施: Morphine, Placebo (Drug)
结局指标
主要结局
Cumulative Amount of Morphine Administered in the First 24 Hours Following Surgery
时间窗: 24 hours post surgery
Total cumulative amount of morphine administered (PCA and/or bolus) in the first 24 hours after the application of the last surgical stitch after prostatectomy.
次要结局
- Cumulative Amount of Morphine Administered in the First 48 Hours Following Surgery(48 hours post surgery)
- Time to Last Administration of Morphine(baseline (end of surgery) to 48 hours post surgery)
- Amount of Blood Loss(48 hours post surgery)
- Number of Participants With Blood Loss Requiring Red Blood Cell (RBC) Transfused Units(48 hours post surgery)
- Pain Intensity Score(12, 24, 36, and 48 hours post surgery)
- Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Severity Composite Score(24 and 48 hours post surgery)
- Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference Composite Score(24 and 48 hours post surgery)
- Opiate Related Symptom Distress Scale (OR-SDS) Questionnaire: Overall Composite Score(24 and 48 hours post surgery)
研究者
研究点 (1)
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