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
Carnot Laboratories
128 participants
Jul 30, 2024
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria3
- 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 Criteria6
- 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
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Interventions
Tegoprazan 50 mg daily for 28 days
Pantoprazole 40 mg daily for 28 days
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06991348