NCT00643799已完成4 期
A Randomized, Multicenter, Double-Blind, Double-Dummy Study Comparing the Efficacy and Tolerability of Once Daily Celebrex (Celecoxib) and Naproxen 500 mg Twice Daily in the 6-month Treatment of Subjects With Osteoarthritis of the Knee
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 586 人开始时间: 2004年3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
- 586
- 试验地点
- 1
- 主要终点
- Number of responders, defined as a 20% improvement from baseline in the The Western Ontario MacMaster (WOMAC)Questionnaire Total Score
研究概览
简要总结
To compare the safety and efficacy of celecoxib versus naproxen for the treatment of knee osteoarthritis
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
- •Osteoarthritis of the knee as defined by the American College of Rheumatology criteria in a flare state at baseline visit
- •Functional Capacity Classification of I-III
排除标准
- •Inflammatory arthritis or gout/pseudo-gout with an acute flare within the past 2 years (subjects with fibrositis or fibromyalgia will not be excluded)
- •Received acetaminophen within 24 hours of the baseline visit
- •Acute joint trauma at index joint within the past 3 months with active symptoms
- •History of gastrointestinal (GI) perforation, obstruction, or bleeding
- •Diagnosed or treated for GI ulcer within 60 days prior to first dose of study medication
- •Received corticosteroids or hyaluronic acid within certain timeframe before study
研究组 & 干预措施
A
Experimental
干预措施: Celecoxib (Drug)
B
Active Comparator
干预措施: Naproxen (Drug)
C
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of responders, defined as a 20% improvement from baseline in the The Western Ontario MacMaster (WOMAC)Questionnaire Total Score
时间窗: Month 6
次要结局
- Number of health care professional contacts(Throughout study)
- Number of hospitalizations, emergency room visits, and procedures(Throughout study)
- Change in WOMAC Subscales from baseline(Month 6)
- Response in VAS(Month 6)
- Adverse events(Throughout study)
- Change in GI Distress Scale from time of discontinuation of study drug(Month 6)
- Patient's and Physician's Satisfaction with Current Arthritis Therapy(Month 6)
- Change in WOMAC Total Score from baseline(Month 6)
- Change in Gastrointestinal (GI) Distress Scale from Week 1(Month 6)
- Change in Work Limitation Questionnaire scale scores from baseline(Month 6)
- Response in each WOMAC Subscale(Month 6)
- Vital signs(Month 6)
- Change in visual analog scale (VAS) from baseline(Month 6)
- Change in Medical Outcome Study sleep scale from baseline(Month 6)
- Change in Patient's and Physician's Global Assessment of Pain from baseline(Month 6)
- Laboratory tests(Month 6)
- Receipt of prescription or over-the-counter gastroprotective agents or pain medications (off study drug)(Throughout study)
- Physical examination(Month 6)
研究者
研究点 (1)
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