NCT00366938已完成3 期
A 13-week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel Trial of 2 Different Dose Regimens of Lumiracoxib (100 mg od and 200 mg od Initial Dose for Two Weeks Followed by 100 mg od) in Patients With Primary Knee Osteoarthritis, Using Celecoxib (200 mg od) as a Comparator
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 1,464
- 试验地点
- 2
- 主要终点
- Overall OA pain intensity in the target knee using a 0-100 mm Visual Analogue Scale (VAS), at week 13.
研究概览
简要总结
This study will investigate the efficacy and safety of lumiracoxib in patients with primary knee osteoarthritis (OA).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary osteoarthritis of knee (confirmed by American College of Rheumatology [ACR] criteria).
- •Requirement of regular non-steroidal anti-inflammatory drug (NSAID) therapy.
排除标准
- •Evidence of active gastrointestinal ulceration within 12 months prior to the screening visit or history of active gastrointestinal bleeding within the previous 5 years.
- •Known hypersensitivity to analgesics, antipyretics, or NSAIDS (including celecoxib).
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Overall OA pain intensity in the target knee using a 0-100 mm Visual Analogue Scale (VAS), at week 13.
Patient's global assessment of disease activity using a 0-100 mm VAS, at week 13.
Patient's functional status using Western Ontario and McMaster Universities Arthritis Index (WOMAC©) total score, at week 13.
次要结局
- Overall OA pain intensity in the target knee using 0-100 mm VAS, at weeks 2, 4, 8.
- Patient's global assessment of disease activity using 0-100 mm VAS, at weeks 2, 4, 8.
- Patient's functional status using WOMAC© Likert 3.1 sub-scale scores and total score, at weeks 2, 8, 13.
- Patient's health status using the Short Form-36 (SF-36), at week 13.
- Physician's global assessment of disease activity using 0-100 mm VAS, at weeks 2, 4, 8.
研究者
研究点 (2)
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