NCT00141154已完成3 期
A Randomized, Multicenter, Active And Placebo Controlled Parallel Group Study To Evaluate The Efficacy And Safety Of Celecoxib (Ym177) 200 Bid Compared To Loxoprofen 60 Mg Tid In Patients With Low Back Pain
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.38 个研究点 分布在 1 个国家目标入组 1,234 人开始时间: 2004年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,234
- 试验地点
- 38
- 主要终点
- Patient's pain assessment (VAS: Visual Analogue Scale)
研究概览
简要总结
To verify the superiority of celecoxib (YM177) 200 mg bid to placebo in treatment of patients with low back pain as well as non-inferiority to loxoprofen sodium 60 mg tid.
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
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have the major site of the low back pain at the 12th thoracic vertebra or lower
- •Patients who have had low back pain for at least two weeks
排除标准
- •Patients who have a previous history or complication of rheumatoid arthritis, spondylarthrosis with negative serum reaction (ankylosing spondylarthritis, psoriatic arthritis), metastasis of tumor, Paget's disease, fibromyalgia, tumor or infection of spinal cord or intervertebral disc, or any other disease which can cause systemic pain
结局指标
主要结局
Patient's pain assessment (VAS: Visual Analogue Scale)
次要结局
- Patient's global assessment (VAS), Physician's global assessment (VAS), Roland Morris Disability Questionnaire (RDQ)
研究者
研究点 (38)
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