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

NCT06991348 | Recruiting Phase 4

• 1 other identifier: CRN-GA-01-2022
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 2

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.

Conditions

Gastroesophageal Reflux Disease

Keywords

GERD; pantoprazole; tegoprazan; P-CAB; PPI

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end of treatment at 4 weeks

Study Arms (4)

Non-erosive GERD - Test product

EXPERIMENTAL

Non-erosive GERD - Tegoprazan

Drug: Tegoprazan

Non-erosive GERD - Comparator

ACTIVE COMPARATOR

Non-erosive GERD - Pantoprazole

Drug: Pantoprazole

Erosive GERD - Test product

EXPERIMENTAL

Erosive GERD - Tegoprazan

Drug: Tegoprazan

Erosive GERD - Comparator

ACTIVE COMPARATOR

Erosive GERD - Pantoprazol

Drug: Pantoprazole

Interventions

Tegoprazan DRUG

Tegoprazan 50 mg daily for 28 days

Erosive GERD - Test product; Non-erosive GERD - Test product

Pantoprazole DRUG

Pantoprazole 40 mg daily for 28 days

Erosive GERD - Comparator; Non-erosive GERD - Comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Carnot Laboratories: lead

Study Sites (2)

Gastrologen S.A. de C.V.

Mexico City, Mexico City, 01900, Mexico

RECRUITING

Saluz Investigación, S.C.

Boca del Río, Veracruz, 94299, Mexico

RECRUITING

Related Publications (1)

• Cho YK, Kim JH, Kim HS, Kim TO, Oh JH, Choi SC, Moon JS, Lee SK, Jung SW, Kim SS, Jung HK, Lee SP, Cheon GJ, Park MI, Jung HY, Ko KH, Sung IK, Lee SH, Lee JY, Lee ST, Rhee PL, Kim N, Hong SJ, Kim HJ, Kim GH, Lee KJ, Kim SK, Shin WG, Lee OY. Randomised clinical trial: comparison of tegoprazan and lansoprazole as maintenance therapy for healed mild erosive oesophagitis. Aliment Pharmacol Ther. 2023 Jan;57(1):72-80. doi: 10.1111/apt.17255. Epub 2022 Oct 31.

  PMID: 36314172 BACKGROUND

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

tegoprazan; Pantoprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jose M Remes-Troche, Dr

  Digestive Physiology and Motility Lab, Instituto de Investigaciones Médico Biológicas, Veracruz , México

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: May 27, 2025
• Study Start: July 30, 2024
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

ME (2)