[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100500657":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":32,"locations":38,"responsibleParty":55,"collaborators":36,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":36,"maxAge":36,"enrollmentInfo":68,"targetDuration":36,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":41,"whyStopped":36,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"The Cleveland Clinic","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Open-capsule","EXPERIMENTAL","Subjects in this arm will be treated with omeprazole 40 milligrams twice daily (or alternative medication if not covered by the subject's insurance) taken as an open-capsule until confirmed ulcer healing.",[13],"Drug: Omeprazole 40 milligrams",{"label":15,"type":16,"description":17,"interventionNames":18},"Intact-capsule","ACTIVE_COMPARATOR","Subjects in this arm will be treated with omeprazole 40 milligrams twice daily (or alternative medication if not covered by the subject's insurance) taken as an intact-capsule until confirmed ulcer healing or potential cross-over.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Omeprazole 40 milligrams","Subjects will be randomized to treatment with either open-capsule or intact-capsule omeprazole to assess effect on ulcer healing times. If interim analysis illustrates significantly improved healing in the open-capsule group, the control (intact-capsule) arm will be allowed to cross-over to open-capsule and be followed until confirmed ulcer healing.",[15,9],[26,27],"Prilosec","Losec",[29],{"name":30,"affiliation":5,"role":31},"Stephen Firkins, MD","PRINCIPAL_INVESTIGATOR",[33],{"name":30,"role":34,"phone":35,"phoneExt":36,"email":37},"CONTACT","216-444-8460",null,"bariatricendoscopy@ccf.org",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Cleveland Clinic Foundation","RECRUITING","Cleveland","Ohio","44195","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-81.69541,41.4995,{"lat":51,"lon":50},[54],{"name":30,"role":34,"phone":35,"phoneExt":36,"email":37},{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"SPONSOR_INVESTIGATOR","Stephen Firkins","Co-Director of Bariatric Endoscopy","100500657","phase-4-open-versus-intact-capsule-proton-pump-inhibitors-for-the-treatment-of-marginal-ulcers-100500657",false,"NCT05799105","OPEN Versus InTact Capsule Proton Pump Inhibitors for the Treatment of Marginal Ulcers","OPEN Versus InTact Capsule Proton Pump Inhibitors for the Treatment of Marginal Ulcers After Bariatric Surgery","OPEN-IT","Inclusion Criteria:\n\n* Subjects diagnosed with marginal ulceration post-gastric bypass on upper endoscopy\n\nExclusion Criteria:\n\n* Refusal to start PPI medication OR current open-capsule PPI use at the time of diagnosis of the marginal ulcer","ALL",{"count":69,"type":70},122,"ESTIMATED","INTERVENTIONAL",[73],"PHASE4","The goal of this clinical trial is to identify the most effective way to take acid-blocking medications to treat stomach ulcers in patients who have undergone gastric bypass surgery. The main questions it aims to answer are:\n\n* is taking an acid-blocking medication by opening the capsule and only taking the contents of the capsule (open-capsule) more or less effective than taking the capsule as a whole (intact-capsule) for treating ulcers in patients who have a history of gastric bypass surgery?\n* does taking the open versus intact medication decrease the number of procedures and complications from untreated ulcers?\n\nParticipants with ulcers will be instructed to take acid-blocking medications (called proton-pump inhibitors) either by opening the capsule and taking only the contents or by taking the capsule whole. These medications are the gold standard for treatment of stomach ulcers. Participants will be asked to undergo an upper endoscopy (EGD) every 3 months to monitor the healing of the ulcers.\n\nResearchers will compare how quickly the ulcers heal depending on which way the medications are taken (opened up or as a whole).",[76],"Marginal Ulcer",[78,79,80,81],"marginal ulcer","bariatric surgery","gastric bypass","open capsule","2026-03-17",{"date":84,"type":85},"2026-03-19","ACTUAL",{"date":87,"type":85},"2023-03-14",{"date":89,"type":70},"2027-03-23",{"name":57,"class":6},1]