NCT00446797已完成4 期
An Open Label Randomized Multicenter Comparative Study On Celecoxib Efficacy And Safety Versus Non-Selective NSAID In Acute Pain Due To Ankle Sprain
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 个研究点 分布在 1 个国家目标入组 278 人开始时间: 2007年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 278
- 试验地点
- 1
- 主要终点
- Change From Baseline at Day 3 in Pain Visual Analog Scale (VAS) - Per Protocol Population
研究概览
简要总结
To assess the efficacy of celecoxib loading dose of 400mg followed by 200 mg twice a day (BID) versus oral non-selective NSAIDs in acute pain due to ankle sprain.
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
- None
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 with first acute ankle sprain episode in the last six months classified as grade I or II, confirmed by X-rays, according to the following definitions:
- •Grade I: When the ligament is stretched but not torn and the anterior talofibular ligament is usually involved. The anterior draw test is negative.
- •Grade II: Moderate sprains which usually result in partial tears af the ligaments, primarily the anterior talofibular and possibly the calcaneofibular ligament. Ligamentous laxity may be present and there is moderate swelling.
排除标准
- •Patients who have a similar injury of the same joint within the last six months; or
- •clinical evidence of complete rupture of ankle ligaments (third degree sprain), or
- •requirements for bed rest, hospitalization, surgical intervention for the ankle injury; or
- •evidence of fractures; or non-removable full cast of any tipe; or
- •presence of bilateral occurrence of ankle injury or ipsilateral ankle and knee injury.
研究组 & 干预措施
Non-Selective NSAIDS
Active Comparator
nsNSAIDs used in real-life standard practice for treatment of pain due to ankle sprain.
干预措施: Non-selective NSAIDS (Drug)
Celecoxib
Experimental
干预措施: Celecoxib (Drug)
结局指标
主要结局
Change From Baseline at Day 3 in Pain Visual Analog Scale (VAS) - Per Protocol Population
时间窗: Baseline and day 3
Assessment of ankle pain by VAS: 100 mm horizontal line with left end being "No Pain" \& right end being "Worst Possible Pain". Participants drew vertical line on horizontal scale to best reflect current pain on full weight bearing of injured ankle. Distance from left end of line to mark. Change: mean score at day 3 minus mean score at baseline
次要结局
- Pain Relief - MITT Population(Days 2, 3 and 7)
- Subject Assessment of Normal Function / Activity(Days 2, 3 and 7)
- Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 3(Days 2, 3 and 7)
- Change From Baseline in Pain Visual Analog Scale (VAS) - Modified Intent to Treat Population(Baseline and days 2, 3 and 7)
- Number of Subjects Responding (Improving) - MITT Population(Days 2, 3 and 7)
- Subject's Global Assessment of Ankle Injury(Days 2, 3 and 7)
- Physician Global Assessment of Ankle Injury(Days 3 and 7)
- Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 1(Days 1, 3 and 7)
- Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 2(Days 2, 3 and 7)
- Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 4(Days 2, 3 and 7)
- Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Index(Days 2, 3 and 7)
- Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5A(Days 2, 3 and 7)
- Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5G(Days 2, 3 and 7)
- Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Index(Days 2, 3 and 7)
- Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5B(Days 2, 3 and 7)
- Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5F(Days 2, 3 and 7)
- Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5C(Days 2, 3 and 7)
- Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5D(Days 2, 3 and 7)
- Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5E(Days 2, 3 and 7)
研究者
研究点 (1)
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