NCT00139607终止3 期
A Multicenter, Open Label, Pilot Study To Evaluate Analgesic Activity And Safety Of Parecoxib 40 Mg IV In Patients Undergoing Hemicolectomy, In The Optimal Management Of Acute Post-Operative Pain Of Surgical Patients
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Evaluation of efficacy assessments based on pain intensity (VAS) and on Pain relief (PR).
研究概览
简要总结
This is a phase III, multicenter, open label, pilot to evaluate the analgesic efficacy and safety of parecoxib 40 mg IV in the treatment of the pain following hemicolectomy in an optimal management of the surgical patient
详细描述
The study was terminated prematurely due to recruitment issues on 31 January 2006. Safety concerns did not lead to the decision to terminate this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients hospitalised for resection of left/right colon;
- •preoperative health graded as ASA <3.
排除标准
- •patients with any type of metastatic cancer, particularly metastatic colon cancer;
- •patients with familial adenomatous polyps (sporadic adenomatous polyps are accepted);
结局指标
主要结局
Evaluation of efficacy assessments based on pain intensity (VAS) and on Pain relief (PR).
次要结局
- Time between the first administration of parecoxib and the first request of morphine The total amount of morphine in the first 24 hours of treatment and the total amount of morphine given during the entire period of treatment with parecoxib
研究者
研究点 (4)
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