NCT00630929已完成4 期
A Study of the Efficacy and Tolerability of Once Daily Celebrex (Celecoxib) and Three Times Daily Ibuprofen vs. Placebo in the 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 388 人开始时间: 2003年1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
- 388
- 试验地点
- 1
- 主要终点
- Change from baseline in patient's assessment of arthritis pain according to visual analogue scale
研究概览
简要总结
To compare the efficacy and safety of celecoxib versus ibuprofen in subjects with osteoarthritis (OA) of the knee.
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
- •Inclusion criteria:
- •Aged >=40 years old
- •Diagnosed with OA of the knee according to the American College of Rheumatology and OA in flare state at baseline visit
- •Functional capacity class of I-III
排除标准
- •Exclusion criteria:
- •Inflammatory arthritis or gout or pseudo-gout with acute flare within the past 2 years (subjects with fibrositis or fibromyalgia will not be excluded)
- •Acute joint trauma at index joint within the past 3 months with active symptoms
- •Score of >=20 on PHQ-9 or score of >=1 on PHQ-9 item i
- •Use of mobility assisting device for <6 weeks or use of walker
研究组 & 干预措施
A
Active Comparator
干预措施: Ibuprofen (Drug)
C
Placebo Comparator
干预措施: Placebo (Drug)
B
Experimental
干预措施: Celecoxib (Drug)
结局指标
主要结局
Change from baseline in patient's assessment of arthritis pain according to visual analogue scale
时间窗: Week 6
次要结局
- Laboratory test results(Week 6)
- Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index(Week 6)
- The Pain Satisfaction Scale(Week 6)
- Measurement of upper gastrointestinal tolerability(Weeks 2 and 6)
- Change from baseline in American Pain Society Modified Brief Pain Inventory Short Form pain scores(Days 1-7)
- Change from baseline in patient's assessment of arthritis pain according to visual analogue scale(Week 2)
- Adverse events(Weeks 2 and 6)
- Vital signs(Weeks 2 and 6)
- Physical examination(Week 6)
- Change from baseline in patient and physician global assessments of arthritis(Weeks 2 and 6)
- The Patient Health Questionnaire (PHQ-9)(Week 6)
研究者
研究点 (1)
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