NCT00120900已完成3 期
A Phase III, 12-week, Multicentre, Double-Blind, Double-Dummy, Randomised, Placebo - and Active Comparator - Contolled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381 XXmg and YYmg Administered Orally Once Daily, in Adults With Osteoarthritis of the Knee
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,340
- 试验地点
- 19
- 主要终点
- Change in OA symptoms at week 12 as measured by scores on subject-completed questionnaires on pain, daily activities and global assessment
研究概览
简要总结
This study was designed to evaluate the effectiveness of GW406381 (a COX-2 inhibitor) in treating the signs and symptoms of osteoarthritis of the knee.
详细描述
A Phase III, 12-week, Multicentre, Double-blind, Double-dummy, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group study to investigate the Efficacy and Safety of GW406381 1mg, 5mg, 10mg, 25mg and 50mg administered orally once daily, in adults with Osteoarthritis of the knee (CXA30007).
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
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
- •Subjects have a primary diagnosis of osteoarthritis of the knee with symptom duration of at least 3 months.
- •Use pain medication, such as a COX-2 inhibitor or NSAID (non-steroidal anti-inflammatory drug) at least 5 days per week.
排除标准
- •History of hypersensitivity or intolerance to pain medications.
- •History of gastroduodenal perforations and/or obstructions.
- •History of upper GI (gastrointestinal) ulceration within the previous 6 months.
- •History of upper or lower GI bleeding within the previous year.
- •History of inflammatory bowel disease.
- •Currently take sucralfate or misoprostol.
- •Currently taking aspirin daily for the heart.
- •Other restrictions around the use medications apply and would need to be discussed.
- •History of coronary artery disease, (angina, MI) or surgery.
- •History of congestive heart failure or renal artery stenosis.
- •History of stroke or transient ischemic attack.
- •History of uncontrolled hypertension.
结局指标
主要结局
Change in OA symptoms at week 12 as measured by scores on subject-completed questionnaires on pain, daily activities and global assessment
次要结局
- Change in OA symptoms as measured by subject and physician-completed questionnaires at each scheduled visit. Percentage of responders, subjects discontinuing due to lack of efficacy, use of rescue medication and health-related quality of life.
研究者
研究点 (19)
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