NCT00139776已完成4 期
Double-Blind Parallel-Group Randomized Study Of Efficacy And Safety Of "Continuous Use" Of Celecoxib Vs. The "Usual Use" Of Celecoxib In The Treatment Of Subjects With Chronic Osteoarthritis Of The Hip Or Knee Who Require an Anti-inflammatory Medication for Control Of Their 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 875 人开始时间: 2005年7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
- 875
- 试验地点
- 1
- 主要终点
- Number of Flare Events Per Time of Exposure to Study Medication
研究概览
简要总结
To determine whether "continuous use" of celecoxib over a 6-month period is more efficacious than "usual or intermittent use" in preventing spontaneous osteoarthritis flares of the knee and hip.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has been diagnosed, according to American College of Rheumatology guidelines, with osteoarthritis of the hip or knee and requires non-steroidal anti-inflammatory drugs (NSAIDs) to control their osteoarthritis pain and have access to a touch-tone telephone.
排除标准
- •Subject has had surgery on index joint.
- •Subject has history of rheumatoid arthritis or fibromyalgia syndrome.
- •Subject has active gastrointestinal or cardiovascular disease.
研究组 & 干预措施
Celecoxib - Continuous use
Active Comparator
干预措施: Celecoxib (Drug)
Celecoxib - Intermittent use
Active Comparator
干预措施: Celecoxib (Drug)
结局指标
主要结局
Number of Flare Events Per Time of Exposure to Study Medication
时间窗: Period III (22 weeks)
Number of flare events per month during Period III (calculated as number of flares divided by number of months participant was enrolled during Period III). Flare was determined using pre-defined criteria, using an interactive voice response system.
次要结局
- Physician's Global Assessment of Arthritis at Final Visit(Period III (22 weeks))
- Total Rescue Medication Taken (Mean)(Period III (22 weeks))
- Days on Flare Medication(Period III (22 weeks))
- Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores(Period III (22 weeks))
- Time to Occurrence of First Osteoarthritis (OA) Flare(Period III (22 weeks))
- Proportion of Days Free From Osteoarthritis (OA) Flare(Period III (22 weeks))
- Patient's Global Assessment of Arthritis(Period III)
- Area Under the Curve (AUCs) of Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores(Period III (22 weeks))
- Proportion of Days in Osteoarthritis (OA) Flare(Period III (22 weeks))
- Arthritis Pain Numerical Rating Scale (NRS)(Period III)
- Proportion of Days on Rescue Medication(Period III (22 weeks))
研究者
研究点 (1)
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