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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01511926
Recruitment Status : Completed
First Posted : January 19, 2012
Last Update Posted : March 10, 2015
Information provided by (Responsible Party):

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.

Condition or disease
Osteoarthritis Rheumatoid Arthritis Ankylosing Spondylitis

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 Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: European Study in Patients With Osteoarthritis, Rheumatoid Arthritis, or Ankylosing Spondylitis at Gastrointestinal Risk: A Retrospective, Non-interventional Study of Vimovo™ Prescribing Patterns
Study Start Date : January 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Adult patients treated with Vimovo™ for diagnosed osteoarthritis (OA), rheumatoid arthritis (RA) or ankylosing spondylitis

Primary Outcome Measures :
  1. Physicians' part of questionnaire score covering speciality, practice setting and NSAIDs prescribing preferences [ Time Frame: baseline ]
  2. Patients' part of questionnaire score covering demography, medical history and Vimovo™ prescribing preferences [ Time Frame: baseline ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients treated with Vimovo™ for diagnosed osteoarthritis (OA), rheumatoid arthritis (RA) or ankylosing spondylitis (AS), and with gastrointestinal (GI) risk factors. The patients will be asked to participate by their treating doctors at GP centres, specialist centres or hospitals across Europe.

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01511926

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Sponsors and Collaborators
Study Director: Javier Nuevo, MSC Medical Department, AstraZeneca Spain

Additional Information:
Responsible Party: AstraZeneca Identifier: NCT01511926     History of Changes
Other Study ID Numbers: D1120C00044
First Posted: January 19, 2012    Key Record Dates
Last Update Posted: March 10, 2015
Last Verified: March 2015

Keywords provided by AstraZeneca:
Vimovo™ treated patients and prescribing patterns
Risk of gastrointestinal side effects

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Spondylitis, Ankylosing
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Bone Diseases, Infectious
Bone Diseases
Spinal Diseases