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

March 9, 2015 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Aalst, Belgium
        • Research Site
      • Dilbeek, Belgium
        • Research Site
      • Erembodegem, Belgium
        • Research Site
      • Genk, Belgium
        • Research Site
      • Halen, Belgium
        • Research Site
      • Heers, Belgium
        • Research Site
      • Huy, Belgium
        • Research Site
      • Langemark, Belgium
        • Research Site
      • Lasne, Belgium
        • Research Site
      • Lembeke, Belgium
        • Research Site
      • Melsele, Belgium
        • Research Site
      • Morkhoven, Belgium
        • Research Site
      • Olen, Belgium
        • Research Site
      • Sart-Lez-Spa, Belgium
        • Research Site
      • Sint-Lievens-Houtem, Belgium
        • Research Site
      • Tessenderlo, Belgium
        • Research Site
      • Wambeek, Belgium
        • Research Site
      • Wingene, Belgium
        • Research Site
      • Zonhoven, Belgium
        • Research Site
  • Finland
      • Helsinki, Finland
        • Research Site
      • Hyvinkaa, Finland
        • Research Site
      • Vantaa, Finland
        • Research Site
  • Germany
      • Bad Bruckenau, Germany
        • Research Site
      • Blankenhain, Germany
        • Research Site
      • Deggingen, Germany
        • Research Site
      • Freiberg, Germany
        • Research Site
      • Gersthofen, Germany
        • Research Site
      • Hagen, Germany
        • Research Site
      • Lienen, Germany
        • Research Site
      • Lohne, Germany
        • Research Site
      • Munchen, Germany
        • Research Site
      • Stockach, Germany
        • Research Site
  • Netherlands
      • Andijk, Netherlands
        • Research Site
      • Beek en Donk, Netherlands
        • Research Site
      • Dordrecht, Netherlands
        • Research Site
      • Eersel, Netherlands
        • Research Site
      • Heesch, Netherlands
        • Research Site
      • Hertogenbosch, Netherlands
        • Research Site
      • Hoogwoud, Netherlands
        • Research Site
      • Midwoud, Netherlands
        • Research Site
      • Nijverdal, Netherlands
        • Research Site
      • Ravenstein, Netherlands
        • Research Site
      • Sint Geertruid, Netherlands
        • Research Site
      • Spijkernisse, Netherlands
        • Research Site
      • Vlodrop, Netherlands
        • Research Site
  • Norway
      • Boverbru, Norway
        • Research Site
      • Eidsvoll, Norway
        • Research Site
      • Kirkenaer, Norway
        • Research Site
      • Krakeroy, Norway
        • Research Site
      • Oslo, Norway
        • Research Site
      • Osteras, Norway
        • Research Site
      • Roa, Norway
        • Research Site
      • Skarnes, Norway
        • Research Site
      • Sola, Norway
        • Research Site
      • Stavanger, Norway
        • Research Site
      • Strommen, Norway
        • Research Site
      • Svelvik, Norway
        • Research Site
      • Tananger, Norway
        • Research Site
      • Tonsberg, Norway
        • Research Site
  • Spain
      • Badalona, Spain
        • Research Site
      • Barcelona, Spain
        • Research Site
      • Benaguasil, Valencia, Spain
        • Research Site
      • Elda, Alicante, Spain
        • Research Site
      • Esplugues de Llobregat, Spain
        • Research Site
      • Merida, Badajoz, Spain
        • Research Site
      • Rianxo, A Coruna, Spain
        • Research Site
      • San Fernando, Cadiz, Spain
        • Research Site
      • Santiago de Compostela, Spain
        • Research Site
      • Sevilla, Spain
        • Research Site
      • Teruel, Spain
        • Research Site
      • Torrelavega, Cantabria, Spain
        • Research Site
      • Valencia, Spain
        • Research Site
      • Vilanova i la Geltru, Spain
        • Research Site
      • Xativa, Valencia, Spain
        • Research Site
      • Zaragoza, Spain
        • Research Site
    • Elche
      • Las Bayas, Elche, Elche, Spain
        • Research Site
  • Switzerland
      • Basel, Switzerland
        • Research Site
      • Bellinzona, Switzerland
        • Research Site
      • Chur, Switzerland
        • Research Site
      • Ebmatingen, Switzerland
        • Research Site
      • Neftenbach, Switzerland
        • Research Site
      • Paradiso, Switzerland
        • Research Site
      • Schiers, Switzerland
        • Research Site
      • Seuzach, Switzerland
        • Research Site
      • St. Erhard, Switzerland
        • Research Site
      • St. Gallen, Switzerland
        • Research Site
      • Zurich, Switzerland
        • Research Site
  • United Kingdom
      • Addingham, United Kingdom
        • Research Site
      • Basildon, United Kingdom
        • Research Site
      • Belfast, United Kingdom
        • Research Site
      • Birmingham, United Kingdom
        • Research Site
      • Chippenham, United Kingdom
        • Research Site
      • Heywood, United Kingdom
        • Research Site
      • Randalstown, United Kingdom
        • Research Site
      • Sheffield, United Kingdom
        • Research Site
      • Warminster, United Kingdom
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
1
Adult patients treated with Vimovo™ for diagnosed osteoarthritis (OA), rheumatoid arthritis (RA) or ankylosing spondylitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Physicians' part of questionnaire score covering speciality, practice setting and NSAIDs prescribing preferences
Time Frame: baseline
baseline
Patients' part of questionnaire score covering demography, medical history and Vimovo™ prescribing preferences
Time Frame: baseline
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Javier Nuevo, MSC, Medical Department, AstraZeneca Spain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

January 10, 2012

First Submitted That Met QC Criteria

January 18, 2012

First Posted (Estimate)

January 19, 2012

Study Record Updates

Last Update Posted (Estimate)

March 10, 2015

Last Update Submitted That Met QC Criteria

March 9, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1120C00044

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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