NCT00660855终止4 期
A Multicenter, Open Label Trial To Evaluate Analgesic Effect Of Intravenous And Subsequent Oral Therapy With Parecoxib/Valdecoxib (Bextra® IM/IV And Bextra®) 40 Mg/Day For Treatment Of Post-Laparoscopic Surgery Pain
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
- 4
- 试验地点
- 1
- 主要终点
- Visual Analog Scale Pain Intensity (0-100 mm), which was evaluated using the change from baseline
研究概览
简要总结
The objectives of this study were to assess the analgesic efficacy and safety of parecoxib/valdecoxib on post-laparoscopic surgery analgesia.
详细描述
This study A3471107 was terminated on February 4th, 2005 due to enrollment difficulties, problems related to need for rescue medication, and perceptions about cardiovascular risk potentially associated with all NSAIDs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who had undergone laparoscopic surgery
- •Patients in need of post-surgical analgesia
排除标准
- •Patients with an unexpected surgical complication which, in the Investigator's opinion, placed the patient at significantly higher risk for post-surgical complication(s), or for non-routine post-operative care requirements
- •Patients who took any nonsteroidal anti-inflammatory drug or any analgesic within 48 hours prior to surgery
研究组 & 干预措施
Arm 1
Other
干预措施: parecoxib/valdecoxib (Drug)
结局指标
主要结局
Visual Analog Scale Pain Intensity (0-100 mm), which was evaluated using the change from baseline
时间窗: Day 3
次要结局
- Visual Analog Scale Pain Intensity(Day 7)
- Categorical Pain Intensity(Day 3 and Day 7)
- Patient pain relief(Day 3 and Day 7)
- Composite Upper Gastrointestinal (UGI) Tolerability measure was calculated; an UGI event was considered if the patient reported at least one of the following: moderate or severe nausea, or moderate or severe abdominal pain, or moderate or severe(Study endpoint)
- Dyspepsia(Study endpoint)
- Adverse events(Day 1, Day 3, and Day 7)
- Patient Global Evaluation(Day 3 and Day 7)
研究者
研究点 (1)
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