About this trial
The objective of this clinical trial is to compare which of the two drugs best resolves symptoms in patients diagnosed with erosive and non-erosive gastroesophageal reflux disease, adult males and females. The main question is What is the proportion of patients with resolution of the main symptoms of gastroesophageal reflux disease at four weeks of treatment with pantoprazole vs tegoprazan.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
With endoscopic diagnosis of GERD or NERD (endoscopy ≤ 15 days old)
With positive impedance pHmetry results (pHmetry ≤ 15 days old)
With recurrent symptoms of heartburn and regurgitation for a previous period ≥ 3 months old
Disqualifiers
With known hypersensitivity to tegoprazan, pantoprazole, or any of the components of each formulation
Subjects with concomitant administration of atazanavir, nelfinavir or rilpivirine
Nephropathic and/or hepatopathic subjects (including non-alcoholic hepatitis)
Subjects with upper gastrointestinal tract bleeding
Trial design
Parallel
Treatments tested in this trial
Tegoprazan
DrugTegoprazan 50 mg daily for 28 days
Pantoprazole
DrugPantoprazole 40 mg daily for 28 days
Treatment groups
Trial outcomes
Primary outcomes
Proportion of subjects with resolution of the main symptoms of gastroesophageal reflux disease
Carlsson-Dent Questionnaire. These tool consists of 7 multiple-choice questions, using a cut-off point ≥ 4 to be considered positive, which qualitatively assesses symptoms associated with GERD and triggering factors such as diet, posture and medications used.
Sponsors and contacts
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