NCT00269191已完成3 期
A 12-Week, Randomized, Placebo- and Active-Comparator-Controlled, Parallel-Group, Double-Blind Study to Assess the Safety and Efficacy of Etoricoxib 30 mg Versus Ibuprofen 2400 mg in Patients With Osteoarthritis (Study 1)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 528
- 主要终点
- Pain and physical function over 12-weeks as assessed by the WOMAC VA 3.0 pain subscale, WOMAC VA 3.0 physical function subscale, and Patient Global Assessment of Disease Status, as well as safety over 12-weeks as assessed by adverse experiences.
研究概览
简要总结
This study was conducted to assess the safety and tolerability of the drug and to evaluate its efficacy in the treatment of osteoarthritis of the hip or knee in men and women.
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
- •Patients with a clinical and radiographic diagnosis of osteoarthritis of the hip or knee
- •Either prior NSAID or Acetaminophen users within the the ARA functional class I,II or III
- •Patients required to demonstrate a "flare" of the signs and symptoms of OA following withdrawal of NSAID treatment
- •Prior acetaminophen users also required to demonstrate greater than a defined minimum level of signs and symptoms of OA.
排除标准
- •No history of concurrent arthritic disease
- •uncontrolled hypertension or an active cardiac condition
- •No history of hepatitis, neoplastic disease, stroke or transient ischemic attack within a specified duration.
结局指标
主要结局
Pain and physical function over 12-weeks as assessed by the WOMAC VA 3.0 pain subscale, WOMAC VA 3.0 physical function subscale, and Patient Global Assessment of Disease Status, as well as safety over 12-weeks as assessed by adverse experiences.
次要结局
- Patient Global Assessment of Response to Therapy, Investigator Global Assessment of Disease Status, Stiffness, and Overall WOMAC scales as assessed over 12-weeks.
研究者
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