[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611785":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":11,"centralContacts":34,"locations":44,"responsibleParty":70,"collaborators":11,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":80,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":11,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":102,"overallStatus":47,"whyStopped":11,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Hospital General de Mexicali","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients receiving n-acetylcysteine\u002Fsimethicone","ACTIVE_COMPARATOR",null,[13,14],"Drug: Premedication with n-acetylcysteine","Drug: Premedication with simethicone",{"label":16,"type":17,"description":11,"interventionNames":18},"Patients receiving placebo","PLACEBO_COMPARATOR",[19],"Drug: Placebo (drinking water)",[21,26,30],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":11},"DRUG","Premedication with n-acetylcysteine","Once the sample size has been calculated, patients who meet the inclusion criteria will be recruited. who will be randomized using the \"Randomized for Clinical Trial\" program for assignment to treatment groups A and B. Group A will receive 600 mg of N-acetylcysteine and 100 mg of simethicone orally 20 to 60 minutes before the procedure, while the control group will receive an equivalent placebo infusion (composed of drinking water). Premedication and placebo will be labeled in containers as medication or placebo by external personnel not involved in the study, and the identification of each bag will be noted on a sheet and kept in an envelope that will be opened at the end of the study. Tolerance will be evaluated. If any adverse events are identified, the principal investigator will be notified for action regarding the management of the adverse event and its reporting.",[9],{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":11},"Placebo (drinking water)","The control group will receive an equivalent placebo infusion (composed of drinking water)",[16],{"type":22,"name":31,"description":32,"armGroupLabels":33,"otherNames":11},"Premedication with simethicone","Once the sample size has been calculated, patients who meet the inclusion criteria will be recruited. who will be randomized using the \"Randomized for Clinical Trial\" program for assignment to treatment groups A and B. Group A will receive 600 mg of N-acetylcysteine and 100 mg of simethicone orally 20 to 60 minutes before the procedure, while the control group will receive an equivalent placebo infusion (composed of drinking water). Premedication and placebo will be labeled in containers as medication or placebo by external personnel not involved in the study, and the identification of each bag will be noted on a sheet and kept in an envelope that will be opened at the end of the study. Tolerance will be evaluated. If any adverse events are identified, the principal investigator will be notified for action regarding the management of the adverse event and its reporting",[9],[35,40],{"name":36,"role":37,"phone":38,"phoneExt":11,"email":39},"Luis Andre Sanchez Perez, Resident","CONTACT","+ 52 6863468689","sanchez.luis3@uabc.edu.mx",{"name":41,"role":37,"phone":42,"phoneExt":11,"email":43},"Jesus Alberto Camacho Escobedo, Gastroenterologist","+ 52 6862146050","jesus13camacho@hotmail.com",[45,62],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Hospital Almater","RECRUITING","Mexicali","Estado de Baja California","21000","Mexico","MX",{"type":54,"coordinates":55},"Point",[56,57],-115.45446,32.62781,{"lat":57,"lon":56},[60],{"name":41,"role":37,"phone":61,"phoneExt":11,"email":43},"01 686 2146050",{"facility":5,"status":47,"city":48,"state":49,"zip":63,"country":51,"countryCode":52,"cosmosGeoPoint":64,"geoPoint":66,"contacts":67},"21100",{"type":54,"coordinates":65},[56,57],{"lat":57,"lon":56},[68],{"name":41,"role":37,"phone":69,"phoneExt":11,"email":43},"55 686 2146050",{"type":71,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100611785","phase-2-premedication-with-n-acetylcysteine-and-simethicone-to-improve-mucosal-visualization-in-elective-upper-endoscopy-100611785",false,"NCT07245095","Premedication With N-acetylcysteine and Simethicone to Improve Mucosal Visualization in Elective Upper Endoscopy","Randomized Controlled Trial to Evaluate the Effect of Premedication With N-acetylcysteine and Simethicone on Mucosal Visibility During Elective Upper Gastrointestinal Endoscopy Using the TUGS Score","NACSIMET","Inclusion Criteria:\n\n* Men and women aged 18 to 70 years old.\n* Patients who agree to participate in the clinical trial.\n* Patients without active gastrointestinal bleeding.\n* Signing of informed consent form.\n\nExclusion Criteria:\n\n* Patients with a history of hypersensitivity to N-acetylcysteine\n* Patients with a history of hypersensitivity to simethicone\n* Patients with a previous endoscopic diagnosis\n* Patients with a history of gastric or bariatric surgery\n* Patients with a history of motor disorders (e.g., scleroderma, diabetic gastroparesis)\n* Patients taking medications that delay gastric emptying (GLP-1 analogues)\n* Pregnant or breastfeeding patients\n* Patients who do not agree to participate in the clinical trial",true,"ALL","18 Years","99 Years",{"count":85,"type":86},132,"ESTIMATED","INTERVENTIONAL",[89],"PHASE2","The goal of this randomized, double-blind, placebo-controlled clinical trial is to assess whether the combination of N-acetylcysteine and simethicone improves mucosal visibility during upper gastrointestinal endoscopy in adults aged 18 to 99 years of both sexes, including both healthy individuals and those with non-bleeding gastrointestinal symptoms.\n\nThe main questions this study aims to answer are:\n\nDoes pre-endoscopy administration of N-acetylcysteine\u002Fsimethicone improve mucosal visualization based on the Toronto Upper Gastrointestinal Cleanliness Score (TUGS)?\n\nIs this combination safe and well tolerated in this patient population?\n\nResearchers will compare patients receiving N-acetylcysteine (600 mg) and simethicone (100 mg) orally 20-60 minutes before the procedure with those receiving placebo (water) to determine if there is a significant improvement in TUGS scores.\n\nParticipants will:\n\nReceive a single oral dose of either N-acetylcysteine\u002Fsimethicone or placebo prior to endoscopy\n\nUndergo a routine upper GI endoscopy\n\nHave mucosal cleanliness evaluated using the TUGS scoring system\n\nBe monitored for any adverse events or intolerance",[92,93,94,95,96,97,98,99,100,101],"Esophagogastroduodenoscopy","Simethicone","N-Acetylcysteine","Premedication","Visualization","Esophagogastroduodensocopy (EGD) Procedure","Placebo - Control","Gastritis Associated With Helicobacter Pylori","Tumor Gastric","Lesions in the Esophagus, Stomach, Duodenum or Rectum",[92,103,95,93,104,105],"Mucous Membrane","Acetylcysteine","Gastrointestinal Tract","2025-11-20",{"date":108,"type":109},"2025-11-24","ACTUAL",{"date":111,"type":109},"2025-09-12",{"date":113,"type":86},"2026-12-31",{"name":5,"class":6},2]