NCT00661635已完成3 期
A Multiple-Dose, Randomized, Double-Blind, Placebo-Controlled Study of the Analgesic Efficacy and Safety of Valdecoxib Compared to Placebo in Patients for Treatment of Post-Surgical Pain From Laparoscopic Cholecystectomy Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 490
- 试验地点
- 1
- 主要终点
- Patient's Global Evaluation of Study Medication
研究概览
简要总结
To evaluate the analgesic efficacy, general safety, and effects on health outcome measures and opioid-related symptoms of 2 valdecoxib dosing regimens compared with placebo in patients with moderate or severe pain following laparoscopic cholecystectomy surgery.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients had required an elective, non-urgent laparoscopic cholecystectomy, as an outpatient procedure, with ASA Class I-III, with a Baseline Pain Intensity of moderate or severe on a categorical scale and ≥45 mm on a VAS (100 mm)
- •Patients were able to get their first dose of study medication within 8 hours after the end of surgery
排除标准
- •Patients could not undergo procedures expected to produce a greater degree of surgical trauma than the laparoscopic cholecystectomy alone, nor have acute pre-operative pain (other than biliary colic) nor chronic pain conditions, nor uncontrolled chronic conditions, nor cancer, nor a laboratory abnormality that the investigator considered to contraindicate study participation
- •Patient had any cognitive impairment that would, in the investigator's opinion, preclude study participation or compliance with protocol mandated procedures
- •Patient had a history of known alcohol, analgesic, or narcotic substance abuse within the one year prior to Screening
- •Patient had any laboratory abnormality at screening, that, in the opinion of the investigator, is not due to the condition requiring surgery and is not expected to resolve post-surgery, and would, therefore, contraindicate study participation
研究组 & 干预措施
Arm 1
Active Comparator
干预措施: valdecoxib (Drug)
Arm 2
Active Comparator
干预措施: valdecoxib (Drug)
Arm 3
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Patient's Global Evaluation of Study Medication
时间窗: Day 2 and Day 3
Summed Pain Intensity (categorical) through 24 hours (SPI 24)
时间窗: Day 2 and Day 3
次要结局
- Time-specific PI (VAS)(Days 2 to 5)
- Patient's Global Evaluation of Study Medication(Day 4 and Day 5)
- Time to first dose of rescue medication(Days 2 to 5)
- Percent of patients who took rescue medication on each study day(Days 2 to 5)
- Amount of rescue medication taken(Days 2 to 5)
- Time between doses of study medication(Days 2 to 5)
- Worst PI (derived from the mBPI-SF)(Days 2 to 5)
- Average PI (derived from the mBPI-SF)(Days 2 to 5)
- SPI 24 (categorical)(Day 4 and Day 5)
- Time-specific PI (categorical)(Days 2 to 5)
- SPI 24 (VAS)(Days 2 to 5)
研究者
研究点 (1)
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