GERD (Gastroesophageal Reflux Disease)
Conditions
Brief summary
The purpose of this study is to evaluate the diagnostic value of tegoprazan for GERD. Patients experiencing typical GERD symptoms, such as heartburn and acid regurgitation, will take either tegoprazan or a placebo once daily for 1 week. Investigators will compare the short-term symptom improvement between the two groups to determine if an early response to tegoprazan can help diagnose GERD.
Interventions
DRUGTegoprazan 50 mg
Tegoprazan 50 mg tablet will be orally administered once daily for 7 days.
DRUGPlacebo
Placebo tablet will be orally administered once daily for 7 days.
Sponsors
HK inno.N Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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. * Baseline Symptom Assessment Questionnaire score of at least 6 at screening. * 7-Day Symptom Assessment Questionnaire score of at least 4 at randomization.
Exclusion criteria
* Known hypersensitivity to Potassium-Competitive Acid Blockers (P-CABs) or benzimidazoles. * 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. * History of or planned gastrointestinal surgery that potentially affects gastric acid secretion. * Diagnosed with Zollinger-Ellison syndrome or other gastric acid secretion disorders. * Endoscopic evidence of esophageal stricture, ulcer stenosis, esophageal varices, Barrett's esophagus (\> 3 cm), eosinophilic esophagitis, gastrointestinal bleeding, active peptic ulcer, or malignant tumor. * 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. * Use of any prohibited medications within the specified wash-out periods or requiring continuous use during the study: 1. Within 2 weeks prior to screening: Acid suppressants (PPIs, P-CABs). 2. Within 1 week prior to screening: Prokinetics, H2 receptor antagonists, gastric mucosal protectors, antacids, or anticholinergics. 3. During the study period (continuous use): Corticosteroids, NSAIDs, antithrombotics, anticoagulants, antipsychotics, antidepressants, or anxiolytics.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic accuracy (Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value) of GERD based on total symptom score | Day 7 |
Secondary
| Measure | Time frame |
|---|---|
| Diagnostic accuracy (Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value) of GERD based on individual symptoms of heartburn and acid regurgitation | Day 7 |
| Diagnostic accuracy (Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value) of GERD based on total symptom score | Day 3 |
| Change from baseline in the 7-day symptom assessment questionnaire score at the end of visit | Baseline and Day 7 (End of Visit) |
| Percentage of patients based on baseline Hospital Anxiety and Depression Scale (HADS) score strata, compared by GERD diagnosis | Baseline and Day 7 (End of Visit) |
| Change from baseline in Gastroesophageal Reflux Disease Questionnaire (GERD-Q) total score at the end of visit | Baseline and Day 7 (End of Visit) |
| Change from baseline in Self-Evaluation Questionnaire for dyspepsia (SEQ-DYSPEPSIA) total score at the end of visit | Baseline and Day 7 (End of Visit) |
Contacts
CONTACTJisu Kim
CONTACTAhrong Kim
PRINCIPAL_INVESTIGATORDo Hoon Kim
Asan Medical Center
Outcome results
None listed