NCT00788710已完成3 期
A Double-Blind, Placebo-Controlled, Multicenter Trial to Study the Efficacy and Tolerability of MK0663/Etoricoxib in the Treatment of Pain After Abdominal Hysterectomy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 430
- 主要终点
- Average Pain Intensity at Rest Over Days 1 to 3
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of etoricoxib compared to placebo in the treatment of postoperative pain associated with total abdominal hysterectomy.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years or older in generally good health who are scheduled to have a total hysterectomy and who are willing to limit alcohol consumption
排除标准
- •Patient is allergic to the study drug, other cyclooxygenase-2 (COX-2) inhibitors/nonsteroidal anti-inflammatory drugs (NSAIDS), ibuprofen, morphine, or oxycodone or has hypersensitivity to aspirin or other NSAIDS
- •Patient has uncontrolled high blood pressure
- •Patient has a history of drug and/or alcohol abuse within the last 5 years
- •Patient has taken part in another investigational study within 4 weeks of the start of study
- •Patient is breast-feeding
- •Patient has an active ulcer or inflammatory bowel disease
研究组 & 干预措施
Etoricoxib 120 mg
Experimental
etoricoxib (MK0663) 120 mg (2 60 mg tablets) and 1 placebo tablet once daily on Days 1-5. Total treatment is 5 days.
干预措施: etoricoxib (MK0663) 120 mg (Drug)
Etoricoxib 90 mg
Experimental
etoricoxib (MK0663) 90 mg tablet and 2 placebo tablets once daily on Days 1-5. Total treatment is 5 days.
干预措施: etoricoxib (MK0663) 90 mg (Drug)
结局指标
主要结局
Average Pain Intensity at Rest Over Days 1 to 3
时间窗: 3 Days
Pain intensity at rest was measured on a 0- to 10-point scale: 0=no pain, to 10=pain as bad as you can imagine.
次要结局
- Average Elicited Pain Upon Sitting Over Days 1 to 3(3 days)
- Average Total Daily Dose of Morphine Over Days 1 to 3(3 days)
研究者
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