A Study to Evaluate the Efficacy and Safety of Tegoprazan in GERD Patients With Nighttime Heartburn

Last updated: August 1, 2023
Sponsor: HK inno.N Corporation
Overall Status: Active - Recruiting

Phase

4

Condition

Gastroesophageal Reflux Disease (Gerd)

Esophageal Disorders

Heartburn (Pediatric)

Treatment

Tegoprazan

Esomeprazole

Clinical Study ID

NCT05701540
IN_APA_403
  • Ages 19-75
  • All Genders

Study Summary

This study aims to compare the nighttime heartburn improvement effect of Tegoprazan 50mg and Esomeprazole 40mg(or 20mg) in patients with GERD.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subjects aged between 19 and 75 years
  2. Subjects who have erosive reflux disease or non-erosive reflux disease

Exclusion

Exclusion Criteria:

  1. Unable to undergo upper GI endoscopy
  2. Symptoms of primary or secondary esophageal movement disorders
  3. Subjects who have undergone or are scheduled to undergo surgery that can affectgastric acid secretion(e.g. upper gastrectomy, vagotomy, etc)

Study Design

Total Participants: 338
Treatment Group(s): 2
Primary Treatment: Tegoprazan
Phase: 4
Study Start date:
March 24, 2023
Estimated Completion Date:
December 31, 2024

Study Description

This is a multi-center, double-blind, randomized, active-controlled phase 4 study. Subjects will be randomly assigned to one of the two treatment groups (tegoprazan 50mg, esomeprazole 40mg or 20mg).

Connect with a study center

  • Severance Hospital

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

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