NCT00476034已完成3 期
A 39-week, Double-blind, Active-controlled Extension to CCOX189A2361, 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
- 1,312
- 试验地点
- 16
- 主要终点
- To compare lumiracoxib 100mg od to celecoxib 200mg od in treating osteoarthritis (OS) of the target knee with respect to:
研究概览
简要总结
This 39-week, active controlled, study is designed to assess long-term efficacy, safety and tolerability of lumiracoxib 100mg od in patients with osteoarthritis (OA) of the knee who participated in the 13-week core CCOX189A2361 study.
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
- •Any patient who completed the core study 2361 may enter the extension trial upon signing informed consent. A patient is defined as completing if he/she completed the core study 2361 up to and including Visit 6 (week 13) without a major protocol violation.
排除标准
- •Those patients for whom continued treatment in the extension study is not considered appropriate by the treating physician
- •Those patients who were non-compliant or who demonstrated a major protocol violation in the core study.
- •Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
To compare lumiracoxib 100mg od to celecoxib 200mg od in treating osteoarthritis (OS) of the target knee with respect to:
Overall OA pain intensity in the target knee on a 0-100 mm Visual Analog Scale (VAS) at 26 weeks.
Patient's global assessment of disease activity on a 0-100mm VAS at 26 weeks.
Patient's functional status using the WOMAC total score at 26 weeks
次要结局
- To assess the efficacy of lumiracoxib as compared to celecoxib with respect to:
- Overall OA pain intensity on a 0-100 mm VAS by visit
- Patient's global assessment of disease activity by visit
- To assess the safety and tolerability profile of lumiracoxib as compared to celecoxib
- Physician's global assessment of disease activity by visit
- Patient's functional status using the WOMAC 3.1 LK sub-scale scores and total score by visit
- Usage of rescue medication
- Response to treatment according to OARSI criteria by visit
研究者
研究点 (16)
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