NCT00296569已完成2 期
A 4-Week, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of MK0686 in Patients With Osteoarthritis of the Knee or Hip
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 主要终点
- Pain relief at the knee and hip over 4 weeks of treatment as assessed by the WOMAC Pain Subscale.
研究概览
简要总结
This study is being conducted to assess the safety and tolerability of MK-0686 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 65 Years（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 ARA functional class I,II or III and with no clinically significant diseases
- •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
- •females must be either post-menopausal or surgically sterilized
排除标准
- •No history of concurrent arthritic disease
- •No history of neoplastic disease within a specified duration
- •No history of disease that causes malabsorption
- •Chronic use of certain medications excluded
结局指标
主要结局
Pain relief at the knee and hip over 4 weeks of treatment as assessed by the WOMAC Pain Subscale.
时间窗: over 4 weeks of treatment
次要结局
- Safety and tolerability over a 4-week treatment period(over a 4-week treatment period)
研究者
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