[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656447":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":11,"studyPopulation":11,"armGroups":43,"interventions":56,"overallOfficials":62,"centralContacts":67,"locations":11,"responsibleParty":77,"collaborators":11,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":11,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":11,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":11,"overallStatus":98,"whyStopped":11,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":11},{"fullName":5,"class":6},"HK inno.N Corporation","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":28},[9],{"measure":10,"description":11,"timeFrame":12},"Diagnostic accuracy (Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value) of GERD based on total symptom score",null,"Day 7",[14,16,18,19,22,24,26],{"measure":15,"description":11,"timeFrame":12},"Diagnostic accuracy (Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value) of GERD based on individual symptoms of heartburn and acid regurgitation",{"measure":10,"description":11,"timeFrame":17},"Day 3",{"measure":15,"description":11,"timeFrame":17},{"measure":20,"description":11,"timeFrame":21},"Change from baseline in the 7-day symptom assessment questionnaire score at the end of visit","Baseline and Day 7 (End of Visit)",{"measure":23,"description":11,"timeFrame":21},"Percentage of patients based on baseline Hospital Anxiety and Depression Scale (HADS) score strata, compared by GERD diagnosis",{"measure":25,"description":11,"timeFrame":21},"Change from baseline in Gastroesophageal Reflux Disease Questionnaire (GERD-Q) total score at the end of visit",{"measure":27,"description":11,"timeFrame":21},"Change from baseline in Self-Evaluation Questionnaire for dyspepsia (SEQ-DYSPEPSIA) total score at the end of visit",[29],{"measure":30,"description":11,"timeFrame":31},"Daily sensitivity and specificity of GERD diagnosis","Daily for 7 days",{"allocation":33,"interventionModel":34,"interventionModelDescription":11,"primaryPurpose":35,"observationalModel":11,"timePerspective":11,"maskingInfo":36},"RANDOMIZED","PARALLEL","DIAGNOSTIC",{"masking":37,"maskingDescription":11,"whoMasked":38},"QUADRUPLE",[39,40,41,42],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[44,50],{"label":45,"type":46,"description":47,"interventionNames":48},"Tegoprazan 50 mg","EXPERIMENTAL","Tegoprazan 50 mg tablet will be orally administered once daily for 7 days.",[49],"Drug: Tegoprazan 50 mg",{"label":51,"type":52,"description":53,"interventionNames":54},"Placebo","PLACEBO_COMPARATOR","Placebo tablet will be orally administered once daily for 7 days.",[55],"Drug: Placebo",[57,60],{"type":58,"name":45,"description":47,"armGroupLabels":59,"otherNames":11},"DRUG",[45],{"type":58,"name":51,"description":53,"armGroupLabels":61,"otherNames":11},[51],[63],{"name":64,"affiliation":65,"role":66},"Do Hoon Kim","Asan Medical Center","PRINCIPAL_INVESTIGATOR",[68,73],{"name":69,"role":70,"phone":71,"phoneExt":11,"email":72},"Jisu Kim","CONTACT","+82 31-5176-4670","jisu.kim@inno-n.com",{"name":74,"role":70,"phone":75,"phoneExt":11,"email":76},"Ahrong Kim","+82 31-5176-4666","ahrong.kim@inno-n.com",{"type":78,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100656447","phase-4-a-study-to-evaluate-tegoprazan-as-a-diagnostic-tool-for-gerd-100656447",false,"NCT07826455","A Study to Evaluate Tegoprazan as a Diagnostic Tool for GERD","Diagnostic Value of Early Response to Tegoprazan in Symptomatic GERD Patients: An Exploratory Clinical Study","Inclusion Criteria:\n\n* Patients aged 19 to 75 years who have experienced symptoms of acid regurgitation or heartburn at least twice a week starting at least 3 months prior to screening.\n* Baseline Symptom Assessment Questionnaire score of at least 6 at screening.\n* 7-Day Symptom Assessment Questionnaire score of at least 4 at randomization.\n\nExclusion Criteria:\n\n* Known hypersensitivity to Potassium-Competitive Acid Blockers (P-CABs) or benzimidazoles.\n* Presence of gastrointestinal warning symptoms (e.g., progressive dysphagia, bleeding, unintentional weight loss within 3 months, hematemesis, anemia, hematochezia, or rectal bleeding) without a confirmed negative tumor finding on endoscopy.\n* History of or planned gastrointestinal surgery that potentially affects gastric acid secretion.\n* Diagnosed with Zollinger-Ellison syndrome or other gastric acid secretion disorders.\n* Endoscopic evidence of esophageal stricture, ulcer stenosis, esophageal varices, Barrett's esophagus (\\> 3 cm), eosinophilic esophagitis, gastrointestinal bleeding, active peptic ulcer, or malignant tumor.\n* Clinically significant hepatic or renal impairment (AST, ALT, ALP, GGT, total bilirubin, and creatinine greater than or equal to 2 times the upper limit of normal \\[ULN\\]) at Screening.\n* Use of any prohibited medications within the specified wash-out periods or requiring continuous use during the study:\n\n  1. Within 2 weeks prior to screening: Acid suppressants (PPIs, P-CABs).\n  2. Within 1 week prior to screening: Prokinetics, H2 receptor antagonists, gastric mucosal protectors, antacids, or anticholinergics.\n  3. During the study period (continuous use): Corticosteroids, NSAIDs, antithrombotics, anticoagulants, antipsychotics, antidepressants, or anxiolytics.","ALL","19 Years","75 Years",{"count":90,"type":91},100,"ESTIMATED","INTERVENTIONAL",[94],"PHASE4","The purpose of this study is to evaluate the diagnostic value of tegoprazan for GERD.\n\nPatients experiencing typical GERD symptoms, such as heartburn and acid regurgitation, will take either tegoprazan or a placebo once daily for 1 week.\n\nInvestigators will compare the short-term symptom improvement between the two groups to determine if an early response to tegoprazan can help diagnose GERD.",[97],"GERD (Gastroesophageal Reflux Disease)","NOT_YET_RECRUITING","2026-09-13",{"date":101,"type":102},"2026-09-17","ACTUAL",{"date":104,"type":91},"2026-09-01",{"date":106,"type":91},"2028-07-31",{"name":5,"class":6}]