NCT00653354已完成3 期
A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Assessment Of The Analgesic Efficacy Of The Dosing Regimen Of Valdecoxib Compared To Placebo Patients In Pain Following Bunionectomy
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
- 360
- 试验地点
- 1
- 主要终点
- Total Pain Relief through 24 hours (TOTPAR 24)
研究概览
简要总结
To assess the analgesic efficacy and general safety of 2 dosing regimens of valdecoxib compared to placebo on the first post-operative day in patients with moderate or severe pain following bunionectomy 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who underwent an uncomplicated primary unilateral first metatarsal bunionectomy surgery (with or without ipsilateral hammer toe repair) requiring open manipulation of bone with periosteal elevation under regional anesthesia (Mayo block)
- •Patients had a Baseline pain intensity of moderate or severe on a categorical scale and ≥45 mm on a VAS
排除标准
- •Patients who were scheduled to undergo other surgical procedures that would be expected to produce a greater degree of surgical trauma than the orthopedic procedure alone
- •Patients treated with patient controlled analgesia (PCA) subsequent to the end of anesthesia
- •Patients treated with long-acting local anesthetics or local anesthetics coadministered with epinephrine injected into the index joint space
- •Patients expected to require analgesics or other agents other than study medication during the 8 hours preceding administration of study medication through the end of the treatment period, that could confound assessment of the analgesic response, specifically excluded were tricyclic antidepressants, tranquilizers, neuroleptics, neuroleptic antiemetics, cyclooxygenase-2 inhibitors, nonsteroidal antiinflammatory drugs, and corticosteroids
研究组 & 干预措施
Arm 2
Active Comparator
干预措施: valdecoxib/placebo (Drug)
Arm 1
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
Total Pain Relief through 24 hours (TOTPAR 24)
时间窗: Day 1
Patient's Global Evaluation of Study Medication
时间窗: Day 1
Summed Pain Intensity Difference (categorical) through 24 hours (SPID 24)
时间窗: Day 1
次要结局
- time between doses of study medication(Day 1)
- time-specific pain relief(2, 4, 6, 8, 10, 12, 16, and 24 hours)
- time-specific PID (VAS)(0, 2, 4, 6, 8, 10, 12, 16, and 24 hours)
- Time-specific Pain Intensity Difference (PID) (categorical)(0, 2, 4, 6, 8, 10, 12, 16, and 24 hours)
- Summed Pain Intensity (SPID)24 (VAS)(0, 2, 4, 6, 8, 10, 12, 16, and 24 hours)
- time to rescue medication(2, 4, 6, 8, 10, 12, 16, and 24 hours)
- Patient's Satisfaction Questionnaire(Day 1)
- percent of patients who took rescue medication(Day 1)
研究者
研究点 (1)
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