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Study Comparing Fexuprazan and Esomeprazole in Patients With Gastroesophageal Reflux Disease

NCT07326904 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2026-01-08

No results posted yet for this study

Summary

The goal of this clinical trial was to evaluate the effectiveness and safety of fexuprazan 40 mg for relieving symptoms of gastroesophageal reflux disease (GERD) in adults. The study also compared fexuprazan with esomeprazole 40 mg, a commonly used treatment for GERD.

The main questions this study aimed to answer were:

* Did fexuprazan reduce GERD symptoms such as heartburn and acid regurgitation?
* Was fexuprazan safe and well tolerated compared with esomeprazole?

Researchers compared fexuprazan with esomeprazole to determine whether fexuprazan provided similar symptom relief and safety.

Participants in the study:

* Were randomly assigned to receive fexuprazan 40 mg or esomeprazole 40 mg once daily
* Took the study medication for 4 weeks, with treatment extended up to 8 weeks if symptoms did not improve
* Attended scheduled clinic visits for evaluations
* Completed symptom questionnaires and a daily symptom diary
* Were monitored for side effects and overall safety throughout the study

Conditions

  • Gastro Oesophageal Reflux Disease

Interventions

DRUG

Fexuprazan

Fexuprazan was administered orally at a dose of 40 mg once daily. Participants received treatment for an initial period of 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with fexuprazan for an additional 4 weeks, for a maximum treatment duration of 8 weeks.

DRUG

Esomeprazole

Esomeprazole was administered orally at a dose of 40 mg once daily. Participants received treatment for an initial period of 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with esomeprazole for an additional 4 weeks, for a maximum treatment duration of 8 weeks.

Sponsors & Collaborators

  • Daewoong Pharmaceutical Co. LTD.

    collaborator INDUSTRY

  • Indonesia University

    lead OTHER

Principal Investigators

  • Ari Fahrial Syam, MD, PhD · Department of Internal Medicine, Faculty of Medicine, Universitas Indonesia / RSUPN Dr. Cipto Mangunkusumo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-23
Primary Completion
2024-10-10
Completion
2024-12-13

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07326904 on ClinicalTrials.gov