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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Enrollment
100
Tegoprazan 50 mg tablet will be orally administered once daily for 7 days.
Placebo tablet will be orally administered once daily for 7 days.
Diagnostic accuracy (Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value) of GERD based on total symptom score
Time frame: Day 7
Diagnostic accuracy (Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value) of GERD based on individual symptoms of heartburn and acid regurgitation
Time frame: Day 7
Diagnostic accuracy (Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value) of GERD based on total symptom score
Time frame: Day 3
Diagnostic accuracy (Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value) of GERD based on individual symptoms of heartburn and acid regurgitation
Time frame: Day 3
Change from baseline in the 7-day symptom assessment questionnaire score at the end of visit
Time frame: 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
Time frame: Baseline and Day 7 (End of Visit)
Change from baseline in Gastroesophageal Reflux Disease Questionnaire (GERD-Q) total score at the end of visit
Time frame: 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
Time frame: Baseline and Day 7 (End of Visit)
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