{
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          "NCTId":"NCT01511926",
          "OrgStudyIdInfo":{
            "OrgStudyId":"D1120C00044"
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          "Organization":{
            "OrgFullName":"AstraZeneca",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"Descriptive Study in Patients Treated With Vimovo™, Including Registration of the Physicians' Prescribing Patterns",
          "OfficialTitle":"European Study in Patients With Osteoarthritis, Rheumatoid Arthritis, or Ankylosing Spondylitis at Gastrointestinal Risk: A Retrospective, Non-interventional Study of Vimovo™ Prescribing Patterns",
          "Acronym":"CHARACTERIZE"
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        "StatusModule":{
          "StatusVerifiedDate":"March 2015",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"March 2014",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"March 2014",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 10, 2012",
          "StudyFirstSubmitQCDate":"January 18, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 19, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"March 9, 2015",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"March 10, 2015",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"AstraZeneca",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"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.",
          "DetailedDescription":"European study in patients with osteoarthritis, rheumatoid arthritis, or ankylosing spondylitis at gastrointestinal risk: A retrospective, non-interventional study of Vimovo™ prescribing patterns"
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Osteoarthritis",
              "Rheumatoid Arthritis",
              "Ankylosing Spondylitis"
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          "KeywordList":{
            "Keyword":[
              "Vimovo™ treated patients and prescribing patterns",
              "Risk of gastrointestinal side effects"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Cohort"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Retrospective"
              ]
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"2000",
            "EnrollmentType":"Anticipated"
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        },
        "ArmsInterventionsModule":{
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            "ArmGroup":[
              {
                "ArmGroupLabel":"1",
                "ArmGroupDescription":"Adult patients treated with Vimovo™ for diagnosed osteoarthritis (OA), rheumatoid arthritis (RA) or ankylosing spondylitis"
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Physicians' part of questionnaire score covering speciality, practice setting and NSAIDs prescribing preferences",
                "PrimaryOutcomeTimeFrame":"baseline"
              },{
                "PrimaryOutcomeMeasure":"Patients' part of questionnaire score covering demography, medical history and Vimovo™ prescribing preferences",
                "PrimaryOutcomeTimeFrame":"baseline"
              }
            ]
          }
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          "EligibilityCriteria":"Inclusion Criteria:\n\nDiagnosis of arthritic disorder (osteoarthritis, rheumatoid arthritis or ankylosing spondylitis) Risk for developing gastrointestinal ulcer Already prescribed Vimovo\n\nExclusion Criteria:\n\nParticipation in any interventional drug study at the time Vimovo™ was prescribed\nPatients started on Vimovo during the first 3 months after country-specific launch date\nPatients started on Vimovo after the study site is initiated (in order to avoid influence on prescribing decision and recruitment)",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          },
          "StudyPopulation":"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.",
          "SamplingMethod":"Non-Probability Sample"
        },
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            "OverallOfficial":[
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                "OverallOfficialName":"Javier Nuevo, MSC",
                "OverallOfficialAffiliation":"Medical Department, AstraZeneca Spain",
                "OverallOfficialRole":"Study Director"
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