[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650600":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":26,"responsibleParty":31,"collaborators":26,"id":35,"slug":36,"hasResults":37,"nctId":38,"briefTitle":39,"officialTitle":40,"acronym":26,"eligibilityCriteria":41,"healthyVolunteers":37,"sex":42,"minAge":43,"maxAge":26,"enrollmentInfo":44,"targetDuration":26,"studyType":47,"phases":48,"briefSummary":51,"conditions":52,"keywords":56,"overallStatus":61,"whyStopped":26,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":26},{"fullName":5,"class":6},"Assiut University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Trimebutine Maleate Group","EXPERIMENTAL","Participants in this group will receive an intravenous administration of 50 mg Trimebutine Maleate approximately 60 to 90 minutes prior to their scheduled urgent upper gastrointestinal endoscopy. All patients will also receive standard medical treatment for acute upper gastrointestinal bleeding according to institutional protocols.",[13],"Drug: Trimebutine Maleate",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo Group","PLACEBO_COMPARATOR","Participants in this group will receive a matching placebo, consisting of an ampoule of saline, administered approximately 60 to 90 minutes prior to their scheduled urgent upper gastrointestinal endoscopy. All patients will also receive standard medical treatment for acute upper gastrointestinal bleeding according to institutional protocols.",[19],"Other: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Trimebutine Maleate","50 mg of Trimebutine Maleate administered intravenously approximately 60 to 90 minutes prior to the scheduled urgent upper gastrointestinal endoscopy.",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo","A matching placebo consisting of an ampoule of saline administered intravenously approximately 60 to 90 minutes prior to the scheduled urgent upper gastrointestinal endoscopy.",[15],{"type":32,"investigatorFullName":33,"investigatorTitle":34,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Mohammad Saleh","Resident of Tropical Medicine and Gastroenterology","100650600","phase-2-trimebutine-maleate-for-enhancing-gastric-visualization-in-acute-upper-gastrointestinal-bleeding-100650600",false,"NCT07749300","Trimebutine Maleate for Enhancing Gastric Visualization in Acute Upper Gastrointestinal Bleeding","Role of Trimebutine Maleate in Enhancing Endoscopic Gastric Visualization in Patients With Acute Upper Gastrointestinal Bleeding: A Double-Blind Randomized Controlled Trial","Inclusion Criteria:\n\n* Age ≥18 years.\n* Clinical evidence of AUGIB: Hematemesis, coffee-ground vomiting or melena.\n* Planned urgent upper gastrointestinal endoscopy within 24 hours.\n\nExclusion Criteria:\n\n* Known gastric outlet obstruction.\n* Previous gastric surgery.\n* Pregnancy or lactation.\n* Allergy to Trimebutine Maleate.\n* Chronic use of prokinetic medications.","ALL","18 Years",{"count":45,"type":46},100,"ESTIMATED","INTERVENTIONAL",[49,50],"PHASE2","PHASE3","Acute upper gastrointestinal bleeding is a medical emergency that requires an urgent upper endoscopy to locate and treat the source of the bleeding. Often, retained blood and clots in the stomach make it difficult for the endoscopist to clearly see the stomach's anatomical structures.\n\nThis study aims to evaluate if administering a medication called Trimebutine Maleate before the endoscopy can help empty the stomach of residual blood and improve the doctor's view. Trimebutine Maleate is a widely prescribed medication that regulates gastrointestinal movement and has a favorable safety profile compared to other medications used for this purpose.\n\nResearchers will include 100 adult patients experiencing acute upper gastrointestinal bleeding who are scheduled for an urgent endoscopy within 24 hours of presentation. Participants will be randomly assigned to receive either 50 mg of intravenous Trimebutine Maleate or a matching placebo (saline solution) 60 to 90 minutes before their procedure. All participants will continue to receive standard medical treatment for their bleeding according to normal hospital protocols.\n\nThe primary goal of the study is to compare the clarity of the stomach view between the two groups using a standardized Gastric Visualization Score. The research team will also measure how often the exact bleeding source is successfully identified, the total duration of the procedure, and whether patients require a repeat endoscopy or a stomach washout (gastric lavage).",[53,54,55],"Acute Upper Gastrointestinal Bleeding","Upper Gastrointestinal Bleeding","Gastrointestinal Hemorrhage",[23,57,58,59,60],"Trimebutine","Gastric Visualization","Endoscopy","Esophagogastroduodenoscopy","NOT_YET_RECRUITING","2026-08-01",{"date":64,"type":65},"2026-08-06","ACTUAL",{"date":67,"type":46},"2026-09",{"date":69,"type":46},"2027-10",{"name":5,"class":6}]