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

Last updated: July 18, 2025
Sponsor: Carnot Laboratories
Overall Status: Active - Recruiting

Phase

4

Condition

Gastroesophageal Reflux Disease (Gerd)

Esophageal Disorders

Heartburn (Pediatric)

Treatment

Tegoprazan

Pantoprazole

Clinical Study ID

NCT06991348
CRN-GA-01-2022
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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 ≥ 3months old

Exclusion

Exclusion Criteria:

  • With known hypersensitivity to tegoprazan, pantoprazole, or any of the components ofeach 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

Total Participants: 128
Treatment Group(s): 2
Primary Treatment: Tegoprazan
Phase: 4
Study Start date:
July 30, 2024
Estimated Completion Date:
November 30, 2025

Connect with a study center

  • Gastrologen S.A. de C.V.

    Mexico, Ciudad de México 01900
    Mexico

    Active - Recruiting

  • Saluz Investigación, S.C.

    Boca del Río, Veracruz 94299
    Mexico

    Active - Recruiting

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