NCT00640627已完成4 期
A Double-Blind, Placebo-Controlled Study of the Efficacy and Tolerability of Once Daily Celebrex® (Celecoxib) vs. Placebo in the Treatment of Subjects With Osteoarthritis of the Knee Non-Responsive to Naproxen and Ibuprofen
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 380 人开始时间: 2003年12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
- 380
- 试验地点
- 1
- 主要终点
- Change from baseline in Patient's Assessment of Arthritis Pain, according to visual analog scale (VAS)
研究概览
简要总结
To compare the safety and efficacy of celecoxib versus placebo in the treatment of patients with knee osteoarthritis who were unresponsive to treatment with prescription strength naproxen and ibuprofen or who could not tolerate prescription strength naproxen and ibuprofen
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
- 40 Years 至 —（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
Experimental
干预措施: Celecoxib (Drug)
B
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in Patient's Assessment of Arthritis Pain, according to visual analog scale (VAS)
时间窗: Week 6
次要结局
- Patient's and Physician's Global Assessment of Pain(Weeks 2 and 6)
- Western Ontario and McMaster Universities Osteoarthritis Index(Week 6)
- The Medical Outcomes Study Sleep Scale(Week 6)
- Adverse events(Weeks 0-6)
- Laboratory tests(Week 6)
- Vital signs(Week 6)
- Physical examination(Week 6)
- Patient's Assessment of Arthritis Pain according to VAS(Week 2)
- Serious adverse events(Up to 30 days after last dose)
研究者
研究点 (1)
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