{ "FullStudy":{ "Rank":217593, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01519375", "OrgStudyIdInfo":{ "OrgStudyId":"NIS-RSE-ATC-2011/1" }, "Organization":{ "OrgFullName":"AstraZeneca", "OrgClass":"INDUSTRY" }, "BriefTitle":"Assessment of NSAID-treated Patients Adherence to Co-prescribed Proton Pump Inhibitor (PPI)", "OfficialTitle":"Cross-sectional, Observational Real Life Study on NSAIDs Treated Patients With Osteoarthritis, Rheumatoid Arthritis and Ankylosing Spondylitis: Assessment of Patient Adherence to PPI Treatment", "Acronym":"CONVOY" }, "StatusModule":{ "StatusVerifiedDate":"May 2012", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"March 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"May 2012", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"May 2012", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 23, 2012", "StudyFirstSubmitQCDate":"January 25, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 26, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"May 28, 2012", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"May 30, 2012", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"AstraZeneca", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The primary objective of this cross-sectional observational real life study is to investigate the patient reported adherence to PPI, when prescribed as prevention of NSAID associated GI Ulcers to patients prescribed a NSAID. Patients included have Osteoarthritis, Rheumatoid Arthritis or Ankylosing Spondylitis. Adherence will be assessed by patient questionnaires.", "DetailedDescription":"Cross-sectional, observational Real Life study on NSAIDs treated patients with Osteoarthritis, Rheumatoid Arthritis and Ankylosing Spondylitis: Assessment of patient adherence to PPI treatment" }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Osteoarthritis", "Rheumatoid Arthritis", "Ankylosing Spondylitis" ] }, "KeywordList":{ "Keyword":[ "Osteoarthritis", "Rheumatoid Arthritis", "Ankylosing Spondylitis" ] } }, "DesignModule":{ "StudyType":"Observational", "DesignInfo":{ "DesignObservationalModelList":{ "DesignObservationalModel":[ "Cohort" ] }, "DesignTimePerspectiveList":{ "DesignTimePerspective":[ "Retrospective" ] } }, "EnrollmentInfo":{ "EnrollmentCount":"102", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"1", "ArmGroupDescription":"Patients with Osteoarthritis, Rheumatoid Arthritis and Ankylosing Spondylitis, 18 years or older" } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Patient reported adherence to PPI treatment on actual days of NSAID treatment.", "PrimaryOutcomeTimeFrame":"7 days" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Proportion of patients with reported adherence ≤ 80%.", "SecondaryOutcomeTimeFrame":"7 days" },{ "SecondaryOutcomeMeasure":"Patient adherence to prescribed ASA treatment.", "SecondaryOutcomeTimeFrame":"7 days" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nConfirmed diagnosis (documented in the medical record) of OA, RA or AS\nPrescription of oral NSAID treatment for OA, RA or AS, where low dose is not sufficient\nPrescription of PPI for prevention of NSAID associated GI ulcers, with instruction to take PPI same day as when taking NSAID.\n\nExclusion Criteria:\n\nParticipating in any clinical trial involving PPI or NSAID\nPatients prescribed PPI as acute treatment of GI events or symptoms within 8 weeks\nInability to complete PROs", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] }, "StudyPopulation":"A total of 100 patients having Osteoarthritis (OA), Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS) selected from medical records at involved clinics. The investigator will select the patients in order of date by latest visits to the clinic and backwards. The patients will be selected from 4-6 involved primary care and and specialist clinics.", "SamplingMethod":"Non-Probability Sample" }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Georgios Stratelis, MD, PhD", "OverallOfficialAffiliation":"AstraZeneca Nordics, B674:4 151 87 Södertälje, Sweden", "OverallOfficialRole":"Study Director" },{ "OverallOfficialName":"Kenneth Henriksson, MD", "OverallOfficialAffiliation":"Reuma City, 111 52 Stockholm, Sweden", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Research Site", "LocationCity":"Kristianstad", "LocationCountry":"Sweden" },{ "LocationFacility":"Research Site", "LocationCity":"Kristinehamn", "LocationCountry":"Sweden" },{ "LocationFacility":"Research Site", "LocationCity":"Limhamn", "LocationCountry":"Sweden" },{ "LocationFacility":"Research Site", "LocationCity":"Partille", "LocationCountry":"Sweden" },{ "LocationFacility":"Research Site", "LocationCity":"Skanor", "LocationCountry":"Sweden" },{ "LocationFacility":"Research Site", "LocationCity":"Stockholm", "LocationCountry":"Sweden" },{ "LocationFacility":"Research Site", "LocationCity":"Ullanger", "LocationCountry":"Sweden" },{ "LocationFacility":"Research Site", "LocationCity":"Vannas", "LocationCountry":"Sweden" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000013166", "ConditionMeshTerm":"Spondylitis" },{ "ConditionMeshId":"D000001168", "ConditionMeshTerm":"Arthritis" },{ "ConditionMeshId":"D000010003", "ConditionMeshTerm":"Osteoarthritis" },{ "ConditionMeshId":"D000001172", "ConditionMeshTerm":"Arthritis, Rheumatoid" },{ "ConditionMeshId":"D000013167", "ConditionMeshTerm":"Spondylitis, Ankylosing" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000007592", "ConditionAncestorTerm":"Joint Diseases" },{ "ConditionAncestorId":"D000009140", "ConditionAncestorTerm":"Musculoskeletal Diseases" },{ "ConditionAncestorId":"D000012216", "ConditionAncestorTerm":"Rheumatic Diseases" },{ "ConditionAncestorId":"D000003240", "ConditionAncestorTerm":"Connective Tissue Diseases" },{ "ConditionAncestorId":"D000001327", "ConditionAncestorTerm":"Autoimmune Diseases" },{ "ConditionAncestorId":"D000007154", "ConditionAncestorTerm":"Immune System Diseases" },{ "ConditionAncestorId":"D000001850", "ConditionAncestorTerm":"Bone Diseases, Infectious" },{ "ConditionAncestorId":"D000007239", "ConditionAncestorTerm":"Infection" },{ "ConditionAncestorId":"D000001847", "ConditionAncestorTerm":"Bone Diseases" },{ "ConditionAncestorId":"D000013122", "ConditionAncestorTerm":"Spinal Diseases" },{ "ConditionAncestorId":"D000025242", "ConditionAncestorTerm":"Spondylarthropathies" },{ "ConditionAncestorId":"D000025241", "ConditionAncestorTerm":"Spondylarthritis" },{ "ConditionAncestorId":"D000000844", "ConditionAncestorTerm":"Ankylosis" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M11509", "ConditionBrowseLeafName":"Osteoarthritis", "ConditionBrowseLeafAsFound":"Osteoarthritis", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M3057", "ConditionBrowseLeafName":"Arthritis", "ConditionBrowseLeafAsFound":"Arthritis", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M3061", "ConditionBrowseLeafName":"Arthritis, Rheumatoid", "ConditionBrowseLeafAsFound":"Rheumatoid Arthritis", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M14544", "ConditionBrowseLeafName":"Spondylitis", "ConditionBrowseLeafAsFound":"Spondylitis", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M14545", "ConditionBrowseLeafName":"Spondylitis, Ankylosing", "ConditionBrowseLeafAsFound":"Ankylosing Spondylitis", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M9204", "ConditionBrowseLeafName":"Joint Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10680", "ConditionBrowseLeafName":"Musculoskeletal Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13628", "ConditionBrowseLeafName":"Rheumatic Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4906", "ConditionBrowseLeafName":"Collagen Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M5047", "ConditionBrowseLeafName":"Connective Tissue Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3210", "ConditionBrowseLeafName":"Autoimmune Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8783", "ConditionBrowseLeafName":"Immune System Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8866", "ConditionBrowseLeafName":"Infection", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4951", "ConditionBrowseLeafName":"Communicable Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3708", "ConditionBrowseLeafName":"Bone Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3711", "ConditionBrowseLeafName":"Bone Diseases, Infectious", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M14502", "ConditionBrowseLeafName":"Spinal Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M21620", "ConditionBrowseLeafName":"Spondylarthropathies", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M21619", "ConditionBrowseLeafName":"Spondylarthritis", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M2751", "ConditionBrowseLeafName":"Ankylosis", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"T5437", "ConditionBrowseLeafName":"Spondylarthropathy", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC05", "ConditionBrowseBranchName":"Muscle, Bone, and Cartilage Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC17", "ConditionBrowseBranchName":"Skin and Connective Tissue Diseases" },{ "ConditionBrowseBranchAbbrev":"BC20", "ConditionBrowseBranchName":"Immune System Diseases" },{ "ConditionBrowseBranchAbbrev":"BC01", "ConditionBrowseBranchName":"Bacterial and Fungal Diseases" },{ "ConditionBrowseBranchAbbrev":"Rare", "ConditionBrowseBranchName":"Rare Diseases" } ] } } } } } }