Text Size

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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01511926
First received: January 10, 2012
Last updated: March 11, 2013
Last verified: March 2013
History of Changes
  Purpose

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
Osteoarthritis
Rheumatoid Arthritis
Ankylosing Spondylitis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Physicians' part of questionnaire score covering speciality, practice setting and NSAIDs prescribing preferences [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Patients' part of questionnaire score covering demography, medical history and Vimovo™ prescribing preferences [ Time Frame: baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 2000
Study Start Date: January 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Adult patients treated with Vimovo™ for diagnosed osteoarthritis (OA), rheumatoid arthritis (RA) or 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01511926

  Show 97 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Javier Nuevo, MSC Medical Department, AstraZeneca Spain
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01511926     History of Changes
Other Study ID Numbers: D1120C00044
Study First Received: January 10, 2012
Last Updated: March 11, 2013
Health Authority: United Kingdom: Research Ethics Committee
The Netherlands: Independent Ethics Committee
Belgium: Institutional Review Board
Spain: Ethics Committee, Ministry of Health
Norway:National Committee for Medical and Health Research Ethics
Finland: National Agency for Medicines, Ethics Committee
Germany: Ethics Commision
Switzerland: Ethikkommission

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

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

ClinicalTrials.gov processed this record on May 22, 2013