[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100341057":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":41,"centralContacts":46,"locations":55,"responsibleParty":70,"collaborators":72,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":10,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":10,"enrollmentInfo":83,"targetDuration":10,"studyType":86,"phases":10,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":58,"whyStopped":10,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"BioDelivery Sciences International","INDUSTRY",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Naldemedine",null,"Patients with chronic non-cancer pain who initiated naldemedine treatment for opioid-induced constipation.",[13],"Drug: Naldemedine",{"label":15,"type":10,"description":16,"interventionNames":17},"Lubiprostone","Patients with chronic non-cancer pain who initiated lubiprostone treatment for opioid-induced constipation.",[18],"Drug: Lubiprostone",{"label":20,"type":10,"description":21,"interventionNames":22},"Naloxegol","Patients with chronic non-cancer pain who initiated naloxegol treatment for opioid-induced constipation.",[23],"Drug: Naloxegol",[25,31,36],{"type":26,"name":9,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","0.2 mg tablet once a day at any time with or without food",[9],[30],"Symproic®",{"type":26,"name":15,"description":32,"armGroupLabels":33,"otherNames":34},"0.024 mg twice a day \\[adjust dose based on liver function\\]",[15],[35],"Amitiza®",{"type":26,"name":20,"description":37,"armGroupLabels":38,"otherNames":39},"25 mg tablet once a day in morning, 1 hour before or 2 hours after food",[20],[40],"Movantik®",[42],{"name":43,"affiliation":44,"role":45},"Stephen Lanes","HealthCore, Inc.","PRINCIPAL_INVESTIGATOR",[47,52],{"name":48,"role":49,"phone":50,"phoneExt":10,"email":51},"Todd Kunkel","CONTACT","913-940-1789","tkunkel@bdsi.com",{"name":53,"role":49,"phone":10,"phoneExt":10,"email":54},"Tom Smith","tsmith@bdsi.com",[56],{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":10},"Research Site","RECRUITING","Wilmington","Delaware","19801","United States","US",{"type":65,"coordinates":66},"Point",[67,68],-75.54659,39.74595,{"lat":68,"lon":67},{"type":71,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[73],{"name":44,"class":6},"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":84,"type":85},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.",[89],"Opioid-induced Constipation",[91,92,93,94,95],"naloxegol","major adverse cardiovascular event (MACE)","opioid induced constipation (OIC)","lubiprostone","naldemedine","2025-02-10",{"date":98,"type":99},"2025-02-12","ACTUAL",{"date":101,"type":99},"2019-01-04",{"date":103,"type":85},"2030-11-01",{"name":5,"class":6},1]