Descriptive Study in Patients Treated With Vimovo™, Including Registration of the Physicians' Prescribing Patterns

Completed

• Conditions: Osteoarthritis; Ankylosing Spondylitis; Rheumatoid Arthritis

• Registration Number: NCT01511926
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-10
• Study First Submitted QC: 2012-01-18
• Study First Posted: 2012-01-19
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-09
• Last Update Posted: 2015-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2000

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Physicians' part of questionnaire score covering speciality, practice setting and NSAIDs prescribing preferences	baseline
Patients' part of questionnaire score covering demography, medical history and Vimovo™ prescribing preferences	baseline

Trial Locations

Locations (1)

Research Site; 🇬🇧 Warminster, United Kingdom