CLINICAL TRIAL FOR THE COMPARATIVE EVALUATION OF ACID SUPPRESSION AND SYMPTOM MANAGEMENT OF GASTROESOPHAGEAL REFLUX DISEASE WITH THE ADMINISTRATION OF TEGOPRAZAN OR PANTOPRAZOLE

Phase 4

Recruiting

• Conditions: Gastroesophageal Reflux Disease
• Interventions: Drug: Tegoprazan; Drug: Pantoprazole

• Registration Number: NCT06991348
• Lead Sponsor: Carnot Laboratories

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-30
• Status Verified: 2025-05
• Study First Submitted: 2025-05-20
• Study First Submitted QC: 2025-05-20
• Last Update Submitted: 2025-05-20
• Study First Posted: 2025-05-27
• Last Update Posted: 2025-05-27
• Primary Completion: 2025-11-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 128

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-erosive GERD - Test product	Tegoprazan	Non-erosive GERD - Tegoprazan
Non-erosive GERD - Comparator	Pantoprazole	Non-erosive GERD - Pantoprazole
Erosive GERD - Test product	Tegoprazan	Erosive GERD - Tegoprazan
Erosive GERD - Comparator	Pantoprazole	Erosive GERD - Pantoprazol

Primary Outcome Measures

Name	Time	Method
Proportion of subjects with resolution of the main symptoms of gastroesophageal reflux disease	From enrollment to the end of treatment at 4 weeks	Carlsson-Dent Questionnaire. A value less than or equal to 4 is considered symptomatic resolution.

Trial Locations

Locations (2)

Gastrologen S.A. de C.V.; 🇲🇽 Mexico, Ciudad De México, Mexico

Saluz Investigación, S.C.; 🇲🇽 Boca del Río, Veracruz, Mexico