NCT00638807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 388 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
- 388
- 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 efficacy and safety of celecoxib versus placebo for the treatment of knee osteoarthritis (OA) in patients who were unresponsive to 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
- •Inclusion criteria:
- •Diagnosed, active, and symptomatic OA of the knee in a flare state with a functional capacity class of I-III at baseline visit
- •Failed adequate trials of both naproxen and ibuprofen (prescription strength) within the past 5 years due to lack of efficacy, tolerability, or both; duration of prescription strength ibuprofen and naproxen must have been a minimum of 2 weeks for each drug at the respective recommended doses if failure was due to lack of efficacy, and for any duration if failure was due to lack of tolerability
排除标准
- •Exclusion criteria:
- •Inflammatory arthritis or gout/pseudo-gout with 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
- •Use of a mobility assisting device for less than six weeks prior to study screening or use of a walker
- •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
Placebo Comparator
干预措施: Placebo (Other)
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 Assessment of Arthritis Pain, according to VAS(Week 2)
- Adverse events(Weeks 0-6)
- Laboratory tests(Week 6)
- The Western Ontario and McMaster Universities Osteoarthritis Index(Week 6)
- Patient's and Physician's Global Assessment of Arthritis(Weeks 2 and 6)
- The Medical Outcomes Study Sleep Scale(Week 6)
- Vital signs(Week 6)
- Physical examination(Week 6)
- Serious adverse events(Up to 30 days after last dose)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Efficacy and Safety of Celecoxib Versus Placebo in the Treatment of Patients With Osteoarthritis of the Knee Who Were Unresponsive to Naproxen and IbuprofenOsteoarthritis, KneeNCT00640627Pfizer's Upjohn has merged with Mylan to form Viatris Inc.380
已完成
4 期
Safety and Efficacy of Celecoxib Versus Naproxen in the 6-month Treatment of Knee OsteoarthritisOsteoarthritis, KneeNCT00643799Pfizer's Upjohn has merged with Mylan to form Viatris Inc.586
已完成
3 期
Etoricoxib vs. Diclofenac in OA (0663-805)(COMPLETED)OsteoarthritisNCT00542087Organon and Co516
已完成
2 期
Study To Evaluate Efficacy And Safety Of An Additional Dose Of Celecoxib (YM177) In Patients With Post-Tooth Extraction PainPainNCT01062113Pfizer's Upjohn has merged with Mylan to form Viatris Inc.255
已完成
4 期
Effect of Celecoxib Versus Placebo Before and After Knee Surgery on Overall Use of Analgesics After SurgeryArthroscopyNCT00633438Pfizer's Upjohn has merged with Mylan to form Viatris Inc.204