NCT00435747撤回4 期
A Double-Blind Comparative Multicenter Study Of The Efficacy And Safety Of Parecoxib IV/IM 40 Mg Vs Placebo On Reducing Opioids Consumption Following Sub Muscular Breast Augmentation Surgery
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- Pfizer
- 主要终点
- To evaluate the opioid-sparing effect of parecoxib 40 mg IV/IM compared to placebo in pre emptive analgesia in patients submitted to sub muscular breast augmentation during the first 24 hours after the first dose of study drug.
研究概览
简要总结
The present study aims to compare the pre-emptive analgesic efficacy of parecoxib 40 mg IV/IM versus placebo on reducing postoperative acute pain following submuscular breast augmentation. Additionally this study is being conducted to evaluate the safety and tolerability of parecoxib in this kind of procedure.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female patients of any ethnic origin aged 18 years or over.
- •The patient is post-menopausal, surgically sterile, or using adequate contraception, not lactating, with a negative urine pregnancy test at screening, prior to administration of study medication.
- •The patient's preoperative health is graded as a class I or II according to the ASA physical status classification and on the basis of medical history and physical examination.
排除标准
- •The patient has significant clinical signs and symptoms suggestive of renal or hepatic morbid conditions
- •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.
- •The patient used analgesics or other agents (antidepressants, sedating antihistamines or other sedatives, muscle relaxants, narcotics, or corticosteroids) during the four hours preceding the procedure that could confound the analgesic responses.
- •Subjects with a history of established ischemic heart disease (e.g. myocardial infarction, stable angina, unstable angina), peripheral arterial disease and/or cerebrovascular disease (e.g. ischemic or hemorrhagic stroke, transient ischemic attack), as well as subjects with previous revascularization procedure to coronary, carotid, cerebral, renal, aortic or peripheral arterial vasculature
结局指标
主要结局
To evaluate the opioid-sparing effect of parecoxib 40 mg IV/IM compared to placebo in pre emptive analgesia in patients submitted to sub muscular breast augmentation during the first 24 hours after the first dose of study drug.
次要结局
- To evaluate the efficacy, safety and tolerability of parecoxib 40 mg IV/IM compared to placebo used to reduce pain following sub muscular breast augmentation in terms of pain intensity
- To evaluate the efficacy, safety and tolerability of parecoxib 40 mg IV/IM compared to placebo used to reduce pain following sub muscular breast augmentation in terms of global evaluation of study medication
- To evaluate the efficacy, safety and tolerability of parecoxib 40 mg IV/IM compared to placebo used to reduce pain following sub muscular breast augmentation in terms of vital signs
- To evaluate the efficacy, safety and tolerability of parecoxib 40 mg IV/IM compared to placebo used to reduce pain following sub muscular breast augmentation in terms of coagulation tests
- To evaluate the efficacy, safety and tolerability of parecoxib 40 mg IV/IM compared to placebo used to reduce pain following sub muscular breast augmentation in terms of adverse events
研究者
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