A 6 Week, Multicenter, Open-label Trial to Evaluate the Safety, Tolerability and Efficacy of Lumiracoxib 200mg o.d. in Patients With Primary Knee Osteoarthritis or Rheumatoid Arthritis

Novartis0 个研究点目标入组 135 人开始时间: 2004年11月1日最近更新: 2012年5月21日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Novartis
入组人数: 135
主要终点: Assess safety and tolerability profile of lumiracoxib in comparison to baseline

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

This study tested the safety, tolerability and efficacy of lumiracoxib - a COX-2 inhibitor- in patients with primary knee osteoarthritis or rheumatoid arthritis.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Treatment
盲法: None

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

•Requirement of regular NSAID therapy
•With primary osteoarthritis of the target knee (by ACR Criteria) or with a diagnosis of rheumatoid arthritis (by ACR Criteria)

排除标准

•Evidence of active ulceration of the UGI tract within 6 months prior to the screening visit or history of active bleeding of the UGI tract within the previous 5 years. As well as with pyloric or duodenal obstruction or with history of gastrointestinal parasites.
•History of cardiac and cerebral thrombotic/ischemic diseases and/or events
•Patients taking additional NSAIDs (including COX-2 inhibitors) during the course of the study.
•Other protocol-defined inclusion/exclusion criteria may apply

结局指标

主要结局

Assess safety and tolerability profile of lumiracoxib in comparison to baseline

次要结局

Demonstrate that lumiracoxib 200mg o.d. is effective in treating OA and pain due to RA with respect to overall OA/ RA pain intensity on a 0-100 mm Visual Analog Scale (VAS) after 6 weeks of treatment in comparison to baseline
Assess efficacy of lumiracoxib compared to baseline with respect to a) overall OA/ RA pain intensity b) patient's and physician's global assessment of disease activity c) patient functional status
Use of rescue medication

研究者

发起方

Novartis

申办方类型

Industry

责任方

Sponsor

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