[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"BioDelivery Sciences International\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":43},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":25,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"100341057","risk-of-major-adverse-cardiovascular-events-for-naldemedine--other-medications-for-opioid-induced-constipation-100341057",false,"NCT03720613","Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation","Risk of Major Adverse Cardiovascular Events Among Users of Naldemedine Compared With Other Medications Used for Opioid Induced Constipation in Adult Patients With Chronic Non-Cancer Pain in a Healthcare Claims Database","Inclusion Criteria:\n\n* At least one dispensing of naldemedine or lubiprostone or naloxegol without prior use in the database of either medication (index date)\n* At least two dispensings of opioids within six months prior to and including the index date, with at least a combined 31 cumulative days supply\n* At least 18 years of age or older on the index date\n* At least six months of continuous health plan coverage that includes medical and pharmacy benefits prior to and including the index date\n\nExclusion Criteria:\n\n* Any acute MACE (non-fatal MI or non-fatal stroke) within six months before or on the index date\n* Any cancer treatment or cancer pain diagnosis within six months before or on the index date\n* Prior use of methylnaltrexone, alvimopan or naloxegol within six months before or on the index date","ALL","18 Years",{"count":19,"type":20},34532,"ESTIMATED","OBSERVATIONAL","The research objective is to characterize the risk of a major adverse cardiovascular event (MACE) among new users of naldemedine versus new users of lubiprostone and new users of naloxegol as comparator opioid induced constipation (OIC) medications.",[24],"Opioid-induced Constipation",[26,27,28,29,30],"naloxegol","major adverse cardiovascular event (MACE)","opioid induced constipation (OIC)","lubiprostone","naldemedine","RECRUITING","2025-02-10",{"date":34,"type":35},"2025-02-12","ACTUAL",{"date":37,"type":35},"2019-01-04",{"date":39,"type":20},"2030-11-01",{"name":41,"class":42},"BioDelivery Sciences International","INDUSTRY",""]