跳至主要内容
临床试验/NCT01511926
NCT01511926已完成不适用

European Study in Patients With Osteoarthritis, Rheumatoid Arthritis, or Ankylosing Spondylitis at Gastrointestinal Risk: A Retrospective, Non-interventional Study of Vimovo™ Prescribing Patterns

AstraZeneca1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
AstraZeneca
入组人数
2,000
试验地点
1
主要终点
Physicians' part of questionnaire score covering speciality, practice setting and NSAIDs prescribing preferences

研究概览

简要总结

The most common pain-relievers used by patients with rheumatic disorders are called non-steroidal anti-inflammatory drugs (NSAIDs). These drugs are effective and well documented, but they can cause ulcers and gastrointestinal side effects. Vimovo™ is a tablet containing naproxen (NSAID) and a gastroprotective agent called esomeprazole. Patients with rheumatic disorders, who are at risk for developing gastrointestinal side effects, and where lower doses of naproxen or other NSAID treatment is not considered sufficient, could use this tablet. The regulatory authorities in many European countries have approved the use of Vimovo™, but they would like to understand how various factors influence the doctors' decision to prescribe the tablet and what is characterizing the patients receiving it. The aim of the study is to answer these questions.

详细描述

European study in patients with osteoarthritis, rheumatoid arthritis, or ankylosing spondylitis at gastrointestinal risk: A retrospective, non-interventional study of Vimovo™ prescribing patterns

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of arthritic disorder (osteoarthritis, rheumatoid arthritis or ankylosing spondylitis) Risk for developing gastrointestinal ulcer Already prescribed Vimovo

排除标准

  • Participation in any interventional drug study at the time Vimovo™ was prescribed
  • Patients started on Vimovo during the first 3 months after country-specific launch date
  • Patients started on Vimovo after the study site is initiated (in order to avoid influence on prescribing decision and recruitment)

结局指标

主要结局

Physicians' part of questionnaire score covering speciality, practice setting and NSAIDs prescribing preferences

时间窗: baseline

Patients' part of questionnaire score covering demography, medical history and Vimovo™ prescribing preferences

时间窗: baseline

次要结局

未报告次要终点

研究者

发起方
AstraZeneca
申办方类型
Industry
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验