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

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.

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Key information

Conditions

Gastroesophageal Reflux Disease Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Gastrologen S.A. de C.V., Mexico City, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tegoprazan

Drug

Tegoprazan 50 mg daily for 28 days

Pantoprazole

Drug

Pantoprazole 40 mg daily for 28 days

Primary outcomes

Proportion of subjects with resolution of the main symptoms of gastroesophageal reflux disease

Time frame: From enrollment to the end of treatment at 4 weeks

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 collaborators

Lead sponsor

Carnot Laboratories

Industry

Registry information

Official study title

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

Acronym: TOP-GERD

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: May 27, 2025
Registry last updated: Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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