NCT00640432已完成4 期
A Multicenter, Randomized, Double-Blind, Double-Dummy Study Of The Safety, Tolerability And Efficacy Of Celecoxib 200 Mg Twice A Day (With A 400 Mg Attack Dose) Versus Sodium Diclofenac 75 Mg Twice A Day In Subjects With Acute Low Back Pain
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 244 人开始时间: 2003年10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
- 244
- 试验地点
- 1
- 主要终点
- Change from baseline in patient-rated visual analogue scale (VAS) pain intensity assessment
研究概览
简要总结
To evaluate the safety and efficacy of celecoxib versus sodium diclofenac in subjects with acute low back pain
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
A
Active Comparator
干预措施: Diclofenac (Drug)
B
Experimental
干预措施: Celecoxib (Drug)
结局指标
主要结局
Change from baseline in patient-rated visual analogue scale (VAS) pain intensity assessment
时间窗: Day 3
次要结局
- Vital signs(Days 3 and 7)
- Adverse events(Days 3 and 7)
- Change from baseline in VAS pain intensity assessment(Day 7)
- Categorical pain intensity score(Days 3 and 7)
- Subject's functional ability, as measured by the "Roland Morris" Questionnaire about low back pain and disability(Day 7)
- Subject's quality of life, as measured by the SF-36 Health Survey(Day 7)
- Physical examination(Days 3 and 7)
- Pain relief score(Days 3 and 7)
- Subject's global assessment score(Days 3 and 7)
研究者
研究点 (1)
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