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

NCT ID: NCT01511926

Last Updated: 2015-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-03-31

Brief Summary

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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

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

Conditions

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Osteoarthritis Rheumatoid Arthritis Ankylosing Spondylitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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1

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

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Javier Nuevo, MSC

Role: STUDY_DIRECTOR

Medical Department, AstraZeneca Spain

Locations

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Aalst, , Belgium

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Dilbeek, , Belgium

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Erembodegem, , Belgium

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Genk, , Belgium

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Halen, , Belgium

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Heers, , Belgium

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Huy, , Belgium

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Langemark, , Belgium

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Lasne, , Belgium

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Lembeke, , Belgium

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Melsele, , Belgium

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Morkhoven, , Belgium

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Olen, , Belgium

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Sart-lez-Spa, , Belgium

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Sint-Lievens-Houtem, , Belgium

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Tessenderlo, , Belgium

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Wambeek, , Belgium

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Wingene, , Belgium

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Zonhoven, , Belgium

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Helsinki, , Finland

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Hyvinkää, , Finland

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Vantaa, , Finland

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Bad Brückenau, , Germany

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Blankenhain, , Germany

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Deggingen, , Germany

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Freiberg, , Germany

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Gersthofen, , Germany

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Hagen, , Germany

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Lienen, , Germany

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Löhne, , Germany

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München, , Germany

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Stockach, , Germany

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's-Hertogenbosch, , Netherlands

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Andijk, , Netherlands

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Beek en Donk, , Netherlands

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Dordrecht, , Netherlands

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Eersel, , Netherlands

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Heesch, , Netherlands

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Hoogwoud, , Netherlands

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Midwoud, , Netherlands

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Nijverdal, , Netherlands

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Ravenstein, , Netherlands

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Sint Geertruid, , Netherlands

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Spijkernisse, , Netherlands

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Vlodrop, , Netherlands

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Bøverbru, , Norway

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Eidsvoll, , Norway

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Kirkenær, , Norway

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Kråkerøy, , Norway

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Oslo, , Norway

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Røa, , Norway

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Skarnes, , Norway

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Sola, , Norway

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Stavanger, , Norway

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Strømmen, , Norway

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Svelvik, , Norway

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Tananger, , Norway

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Tønsberg, , Norway

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Østerås, , Norway

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Las Bayas, Elche, Elche, Spain

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Badalona, , Spain

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Barcelona, , Spain

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Benaguasil, Valencia, , Spain

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Elda, Alicante, , Spain

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Esplugues de Llobregat, , Spain

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Merida, Badajoz, , Spain

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Rianxo, A Coruna, , Spain

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San Fernando, Cadiz, , Spain

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Santiago de Compostela, , Spain

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Seville, , Spain

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Teruel, , Spain

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Torrelavega, Cantabria, , Spain

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Valencia, , Spain

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Vilanova i la Geltrú, , Spain

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Xativa, Valencia, , Spain

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Zaragoza, , Spain

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Basel, , Switzerland

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Bellinzona, , Switzerland

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Chur, , Switzerland

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Ebmatingen, , Switzerland

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Neftenbach / Dorf Neftenbach, , Switzerland

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Paradiso, , Switzerland

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Sankt Gallen, , Switzerland

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Schiers, , Switzerland

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Seuzach Dorf, , Switzerland

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St. Erhard, , Switzerland

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Zurich, , Switzerland

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Addingham, , United Kingdom

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Basildon, , United Kingdom

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Belfast, , United Kingdom

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Birmingham, , United Kingdom

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Chippenham, , United Kingdom

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Heywood, , United Kingdom

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Randalstown, , United Kingdom

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Sheffield, , United Kingdom

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Warminster, , United Kingdom

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Countries

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Belgium Finland Germany Netherlands Norway Spain Switzerland United Kingdom

Related Links

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Other Identifiers

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D1120C00044

Identifier Type: -

Identifier Source: org_study_id

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