NCT00154219已完成3 期
A 13-week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel Group Trial of Lumiracoxib (COX189) 100 mg o.d. in Patients With Primary Hip Osteoarthritis Using Celecoxib (200 mg o.d.) as a Positive Control
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
- 1,200
- 试验地点
- 6
- 主要终点
- Patient's global assessment of disease activity (VAS) after 13 weeks of treatment
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, tolerability, and safety of the investigational drug, lumiracoxib as compared to celecoxib and placebo in subjects with hip osteoarthritis. Both lumiracoxib and celecoxib belong to the same class of drug (COX-2 selective nonsteroidal anti-inflammatory drugs [NSAIDs]).
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
- •Diagnosis of primary hip osteoarthritis
- •Qualifying pain intensity in the hip joint
- •Requiring NSAID therapy
排除标准
- •Rheumatoid arthritis or other inflammatory joint disease
- •Disease or disorder that may interfere with pain assessment of the hip
- •Open knee/hip surgery within the last year
- •Past history of heart attack, stroke or angina (chest pain)
- •Liver disorder
- •History of severe adverse reactions of any kind under lumiracoxib or celecoxib treatment
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Patient's global assessment of disease activity (VAS) after 13 weeks of treatment
WOMAC 3.1 LK questionnaire after 13 weeks of treatment
次要结局
- Overall OA pain intensity (VAS)by visit
- Physician's global assessment of disease activity (VAS) by visit
- Actual OA pain intensity at 12 hours post-dose by visit
- Number of rescue tablets taken during the study
- Response to treatment according to OARSI criteria by visit
研究者
研究点 (6)
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