[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100202125":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":10,"locations":10,"responsibleParty":26,"collaborators":10,"id":28,"slug":29,"hasResults":30,"nctId":31,"briefTitle":32,"officialTitle":33,"acronym":10,"eligibilityCriteria":34,"healthyVolunteers":30,"sex":35,"minAge":36,"maxAge":10,"enrollmentInfo":37,"targetDuration":10,"studyType":40,"phases":10,"briefSummary":41,"conditions":42,"keywords":44,"overallStatus":50,"whyStopped":10,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":10},{"fullName":5,"class":6},"Janssen Research & Development, LLC","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Domperidone\u002F a proton pump inhibitor\u002Fmetoclopramide users",null,"Study patients had at least one prescription for domperidone, a proton pump inhibitor, or metoclopramide. Proton pump inhibitors observed in this study are: omeprazole, lansoprazole, esomeprazole, rabeprazole, and pantoprazole.",[13],"Drug: No intervention",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","No intervention","This is an observational and a retrospective study of existing data, so there will be no interventions. The exposure groups will be domperidone, proton pump inhibitors (omeprazole, lansoprazole, esomeprazole, rabeprazole, and pantoprazole), and metoclopramide.",[9],[21],"Motilium",[23],{"name":24,"affiliation":5,"role":25},"Janssen Research & Development, LLC Clinical Trial","STUDY_DIRECTOR",{"type":27,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100202125","an-observational-study-to-assess-the-risk-of-out-of-hospital-sudden-cardiac-death-in-users-of-domperidone-users-of-proton-pump-inhibitors-and-users-of-metoclopramide-100202125",false,"NCT01907633","An Observational Study to Assess the Risk of Out-of-Hospital Sudden Cardiac Death in Users of Domperidone, Users of Proton Pump Inhibitors, and Users of Metoclopramide","Post-Authorization Safety Study: Risk of Out-of-Hospital Sudden Cardiac Death in Users of Domperidone, Users of Proton Pump Inhibitors, and Users of Metoclopramide","Inclusion criteria:\n\n\\- Patients registered in English practices whose data are linkable to Hospital Episode Statistics (HES) and Office for National Statistics, UK (ONS). Patients are required to have at least 1 year in the Clinical Practice Research Datalink before they can enter the study\n\nExclusion criteria:\n\n* Patients with a diagnosis of cancer other than non-melanoma skin cancer\n* Patients from practices not linkable to HES and ONS data\n* Patient time corresponding to the period between hospital admission date and 30 days after discharge date","ALL","2 Years",{"count":38,"type":39},15000,"ACTUAL","OBSERVATIONAL","The purpose of this observational study is to assess the risk of out-of-hospital Sudden Cardiac (heart) Death (SCD) associated with current use of domperidone compared to current use of a Proton Pump Inhibitor (PPI), current use of metoclopramide, or non-use of any of these medications.",[43],"Death, Sudden, Cardiac",[43,45,46,47,48,49],"Risk of Sudden Cardiac Death","Domperidone","Proton Pump Inhibitors (PPI)","Metoclopramide","Observational Study","COMPLETED","2015-05-18",{"date":53,"type":54},"2015-05-19","ESTIMATED",{"date":56,"type":10},"2011-12",{"date":58,"type":39},"2013-12",{"name":5,"class":6}]