NCT00657449终止4 期
A Double-blind, Double-dummy, Multicenter Randomized Study Of The Efficacy And The Tolerability Of Valdecoxib 40mg Vs Rofecoxib 50mg In The Symptomatic Treatment Of Patients With Ankle Sprain
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
- 45
- 试验地点
- 8
- 主要终点
- change from baseline in visual analogue scale (VAS) pain intensity
研究概览
简要总结
The study compares valdecoxib 40 mg once daily vs. rofecoxib 50 mg one daily in treating the signs and symptoms of acute first- or second-degree ankle sprain. The study also evaluated the disability status, tolerability and safety of these treatments.
详细描述
A3471007 terminated early (30Sep2004) due to safety concerns about continued usage of rofecoxib after worldwide withdrawal of rofecoxib by Merck & Co Inc
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 had sustained, no more than 48 hours prior to the first dose of study medication, a first- or second-degree ankle sprain of the lateral ligament, specifically: anterior talofibular ligament and/or posterior talofibular ligament and/or calcaneofibular ligament
- •At presentation, all patients were to have Patient's Assessment of Ankle Pain Visual Analog Scale (VAS) (0-100mm) of ≥45 mm in the orthostatic position on full weight bearing (ie, moderate to severe pain), had a minimum rating of 2 on the Patient's Global Assessment of Ankle Injury and Patient's Assessment of Normal Function/Activity
- •Tthe investigator opinion was that each patient required, and was eligible for, therapy with an anti-inflammatory agent and/or analgesics to control symptoms
排除标准
- •None reported
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: rofecoxib (Drug)
结局指标
主要结局
change from baseline in visual analogue scale (VAS) pain intensity
时间窗: Day 4
次要结局
- patient's and physician's global assessment of ankle injury(Days 1, 4 and 8)
- patient's and physician's satisfaction assessments(Day 8)
- patient's assessment of normal function/activity(Days 1, 4 and 8)
- patient's assessment of ankle pain VAS (0-100 mm)(Days 1, 4 and 8)
- adverse events, physical examinations, and baseline clinical laboratory values(Adverse Events: Days 1, 4 and 8; Physical examinations: days 1 and 8; Lab tests: day 1)
研究者
研究点 (8)
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