Descriptive Study in Patients Treated With Vimovo™, Including Registration of the Physicians' Prescribing Patterns (CHARACTERIZE)
Status
Conditions
Details and patient eligibility
About
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.
Full description
European study in patients with osteoarthritis, rheumatoid arthritis, or ankylosing spondylitis at gastrointestinal risk: A retrospective, non-interventional study of Vimovo™ prescribing patterns
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Diagnosis of arthritic disorder (osteoarthritis, rheumatoid arthritis or ankylosing spondylitis) Risk for developing gastrointestinal ulcer Already prescribed Vimovo
Exclusion criteria
- 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)
Trial design
2,000 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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