NCT00170781已完成4 期
A 1-Week, Multi-Center, Randomized, Double-Blind, Double-Dummy, Active-Controlled, Parallel Trial Comparing Lumiracoxib (400 mg Once Daily) in Patients With Acute Flares of Gout, Using Indomethacin (50 mg Three Times a Day)
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 234
- 试验地点
- 4
- 主要终点
- Pain intensity in the study joint over days 2 to 5 approximately 4h after the first daily dose
研究概览
简要总结
This study is designed to develop our understanding of the efficacy and safety of using lumiracoxib in the treatment of patients with acute gout. This is a multi-center, double-blind, randomized, parallel group study comparing a single daily dose of 400 mg lumiracoxib with the established dose of indomethacin 50 mg taken three times a day in terms of efficacy
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
- •Ambulatory cooperative male or female patients of at least 18 years of age
- •With an acute attack of gout in 4 joints or less, diagnosed clinically according to the ACR 1977 classification criteria and with an onset within the last 48 hours prior to evaluation. Where more than one joint is involved, the most affected joint should be identified, as the study joint, at baseline and followed throughout the study
- •Who present at Baseline with an acute pain intensity of at least moderate.
排除标准
- •With an acute attack of gout before the last 48 hours prior to evaluation
- •With polyarticular gout involving > 4 joints
- •With rheumatoid arthritis, infectious arthritis, pseudo-gout or other acute inflammatory arthritides.
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Pain intensity in the study joint over days 2 to 5 approximately 4h after the first daily dose
次要结局
- Safety and tolerability profile
- Pain intensity in the study joint over the entire treatment period
- Patient's and Physician's global assessment of response to therapy
- Physician's assessment of tenderness and swelling of study joint
- C-reactive protein level
- Proportion of patients who discontinued treatment because of a lack of efficacy
- Usage of rescue medication
- SF-36 and EQ-5D
- Physician's assessment of erythema of study joint
研究者
研究点 (4)
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