Clinical Trial for the Comparative Evaluation of Acid Suppression and Symptom Management of Gastroesophageal Reflux Disease With the Administration of Tegoprazan or Pantoprazole

Multicenter, Active-controlled, Randomized, Double-blind, Clinical Trial for the Comparative Evaluation of Acid Suppression and Symptom Management of Gastroesophageal Reflux Disease With the Administration of Tegoprazan or Pantoprazole: TOP-GERD

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Subjects with gastric and/or duodenal ulcer 2 months prior to screening
• Subjects with a history of esophageal or gastric surgery