NCT00683137已完成3 期
Clinical Protocol for 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 Bunionectomy 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
- 450
- 试验地点
- 1
- 主要终点
- Patient's Global Evaluation of Study Medication
研究概览
简要总结
The study was done to evaluate the pain relief and safety of 2 valdecoxib doses compared to placebo in patients with moderate or severe pain following bunionectomy surgery, and to evaluate the effect of the 2 valdecoxib doses compared to placebo on health outcome measures and on the occurrence of opioid related symptoms.
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) who required open manipulation of bone with periosteal evaluation under general anesthesia (Mayo block)
- •Patients with a baseline pain intensity (VAS) of greater than or equal to 45 mm
- •Patients with a baseline pain intensity (categorical) of moderate or severe
排除标准
- •Patients scheduled to undergo other surgical procedures that would be expected to produce a greater degree of surgical trauma than the orthopedic procedure alone
- •Treatment with patient-controlled analgesia (PCA) subsequent to the end of anesthesia
- •Long-acting local anesthetics or local anesthetics coadministered with epinephrine injected into the index joint space
- •Use of tricyclic antidepressants, tranquilizers, neuroleptics, neuroleptic antiemetics, COX-2 inhibitors, NSAIDs, and corticosteroids
- •Use of NSAID or analgesia after midnight the night prior to surgery or unwilling to abstain from NSAIDs or other analgesics, except as specified in the protocol, during the study
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
Active Comparator
干预措施: valdecoxib/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 (SPI) (categorical) through 24 hours
时间窗: Day 2 and Day 3
次要结局
- Health Outcomes Post-Discharge Recovery Experience(Days 2 to 5)
- adverse events(continuous)
- Time to first dose of rescue medication (rescue analgesic medication)(Days 2 to 5)
- SPI 24 (categorical)(Day 4 and Day 5)
- Time-specific Pain Intensity (PI) (categorical)(Days 2 to 5)
- SPI 24 (Visual Analog Scale [VAS])(Days 2 to 5)
- Time-specific PI (VAS)(Days 2 to 5)
- Patient's Global Evaluation of Study Medication(Day 4 and Day 5)
- Percent of patients who took rescue medication (rescue analgesic medication)(Days 2 to 5)
- Worst Pain Intensity (derived from the Modified BPI-Short Form)(Days 2 to 5)
- Time between doses of study medication(Days 2 to 5)
- Individual and Composite Pain Interference Score (derived from the modified BPI-Short Form)(Days 2 to 5)
- Symptom Distress Questionnaire(Days 2 to 5)
- Average Pain Intensity (derived from the Modified BPI-Short Form)(Days 2 to 5)
- Amount of rescue medication (rescue analgesic medication) taken(Days 2 to 5)
研究者
研究点 (1)
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