临床试验/NCT02182726

NCT02182726已完成不适用

COX-2 Postmarketing Surveillance Study With MOBEC® 15 mg Tablets

Boehringer Ingelheim0 个研究点目标入组 4,760 人开始时间: 2001年5月最近更新: 2014年7月9日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Boehringer Ingelheim
入组人数: 4,760
主要终点: Assessment of efficacy by physician on a 5-point scale

研究概览研究设计入排标准研究组 & 干预措施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

The aim of the study is to investigate

the indication for MOBEC in a dose of 15 mg per day
the treatments patients were receiving before switching to 15 mg MOBEC
how treatment with 15 mg is assessed compared with previous treatment
how effective and safe treatment with 15 mg MOBEC is considered

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

性别: All
接受健康志愿者: 否

入选标准

•An indication for a treatment with 15 mg MOBEC of at least four weeks
•the symptomatic short-term treatment of osteoarthritis
•the symptomatic long-term treatment of rheumatoid arthritis (chronic polyarthritis); restriction: the recommended dose for long-term treatment of elderly patients is 7.5 mg)
•the symptomatic treatment of ankylosing spondylitis

排除标准

•Treatment with MOBEC prior to the start of the study
•Patients with any of the general or specific contraindications of MOBEC

研究组 & 干预措施

MOBEC

干预措施: MOBEC (Drug)

结局指标

主要结局

Assessment of efficacy by physician on a 5-point scale

时间窗: up to week 8

Nature and incidence of adverse drug reactions (ADR)

时间窗: up to week 8

Assessment of tolerability by physician on a 5-point scale

时间窗: up to week 8

次要结局

未报告次要终点

研究者

发起方

Boehringer Ingelheim

申办方类型

Industry

责任方

Sponsor

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