Study Comparing Fexuprazan and Esomeprazole in Patients With Gastroesophageal Reflux Disease

December 26, 2025 updated by: Ari Fahrial Syam, Indonesia University

A Multi-Center, Randomized, Open-Label Study to Evaluate Symptom Relief and Safety After Using Fexuprazan 40 Mg Compared to Esomeprazole 40 Mg in Patients With Gastroesophageal Reflux Disease (GERD)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This multicenter, randomized, open-label, active-controlled clinical study was conducted to evaluate the efficacy and safety of fexuprazan 40 mg, a potassium-competitive acid blocker (P-CAB), compared with esomeprazole 40 mg, a proton pump inhibitor (PPI), in adult patients with gastroesophageal reflux disease (GERD).

GERD is a chronic condition characterized by reflux-related symptoms such as heartburn and acid regurgitation, which can significantly impair quality of life. Although PPIs are widely used as first-line therapy, limitations including delayed onset of action and insufficient control of nocturnal symptoms have been reported. Fexuprazan, a novel P-CAB, inhibits gastric acid secretion through reversible and potassium-competitive inhibition of the H⁺/K⁺-ATPase and has demonstrated rapid onset and sustained acid suppression in prior clinical studies.

Eligible participants were randomized in a 1:1 ratio to receive either fexuprazan 40 mg or esomeprazole 40 mg administered orally once daily. The initial treatment period was 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period were eligible to continue the assigned treatment for an additional 4 weeks, for a total treatment duration of up to 8 weeks.

Efficacy was assessed primarily through patient-reported symptom evaluation using validated questionnaires and daily symptom diaries. Safety assessments included monitoring of adverse events, vital signs, physical examinations, and laboratory evaluations throughout the study and during follow-up.

The study was conducted in accordance with the principles of the Declaration of Helsinki, International Council for Harmonisation Good Clinical Practice (ICH-GCP), and applicable local regulatory requirements. Written informed consent was obtained from all participants prior to the performance of any study-related procedures.

Study Type

Interventional

Enrollment (Actual)

145

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, Indonesia, 10340
        • Menteng Mitra Afia Jakarta Hospital
      • Jakarta Pusat, DKI Jakarta, Indonesia, 10510
        • Islam Cempaka Putih Jakarta Hospital
    • West Java
      • Depok, West Java, Indonesia, 16424
        • University of Indonesia Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged 18 to 60 years at the time of providing written informed consent
  • Male or female participants
  • History of gastroesophageal reflux disease (GERD) symptoms, including heartburn and/or acid regurgitation

  • GERD symptoms confirmed by:

    • GERD-Q score greater than 7, and
    • Heartburn and/or acid regurgitation occurring on more than 3 days within the last 7 days
  • Able to understand the study procedures and complete questionnaires and a daily symptom diary
  • Willing and able to provide written informed consent

Exclusion Criteria:

Gastrointestinal conditions:

  • Diagnosis of inflammatory bowel disease (Crohn's disease, ulcerative colitis), primary esophageal motility disorders, or pancreatitis
  • History of gastric or esophageal surgery affecting acid secretion (except appendectomy, cholecystectomy, or endoscopic polypectomy of benign polyps)
  • Alarm symptoms suggestive of gastrointestinal malignancy (e.g., severe dysphagia, odynophagia, gastrointestinal bleeding, anemia, unexplained weight loss), unless malignancy was ruled out

Medical history

  • Clinically significant hepatic, renal, endocrine, hematologic, oncologic, or urinary system disease
  • History of malignancy within the past 5 years (except non-digestive malignancies that were completely treated with no recurrence for ≥5 years)
  • History of psychosis, substance abuse, or alcohol abuse
  • Known HIV infection, active hepatitis B, or hepatitis C infection (HCV RNA-positive)

Medication and treatment

  • Use of prohibited concomitant medications within 2 weeks prior to enrollment or need for continuous prohibited medication during the study, including:

    • Proton pump inhibitors, potassium-competitive acid blockers, H2-receptor antagonists, or other acid-suppressive agents
    • Certain psychotropic drugs, anticholinergic drugs, antispasmodics, systemic steroids, or mucoprotective agents
  • Use of another investigational product within 4 weeks prior to study drug administration

Laboratory findings

  • Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin ≥2 times the upper limit of normal
  • Serum creatinine or blood urea nitrogen ≥2 times the upper limit of normal

Reproductive status

  • Pregnant or breastfeeding women
  • Women of childbearing potential or male participants who were unwilling to use appropriate contraception during the study

Other

  • Known hypersensitivity to the investigational product or comparator drug
  • Any condition that, in the opinion of the investigator, made the participant unsuitable for study participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fexuprazan 40 mg
Participants assigned to this arm received fexuprazan 40 mg, a potassium-competitive acid blocker (P-CAB), administered orally once daily. The initial treatment period was 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with fexuprazan 40 mg for an additional 4 weeks, for a maximum treatment duration of 8 weeks. Treatment adherence and safety were monitored throughout the study period according to the protocol.
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.
Active Comparator: Esomeprazole 40 mg
Participants assigned to this arm received esomeprazole 40 mg, a proton pump inhibitor, administered orally once daily. The initial treatment period was 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with esomeprazole 40 mg for an additional 4 weeks, for a maximum treatment duration of 8 weeks. Treatment adherence and safety were monitored throughout the study period according to the protocol.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants With Symptom Relief at Week 4 (GERD-Q Score <8)
Time Frame: 4 weeks
Symptom relief was assessed using the Gastroesophageal Reflux Disease Questionnaire (GERD-Q). The primary outcome was defined as the proportion of participants with a GERD-Q total score of less than 8 at Week 4, indicating adequate relief of GERD symptoms. The GERD-Q is a validated, patient-reported questionnaire that evaluates the frequency and severity of reflux-related symptoms, including heartburn and acid regurgitation.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants With Symptom Relief at Week 8 (GERD-Q Score <8)
Time Frame: 8 weeks
The proportion of participants who achieved symptom relief at Week 8, defined as a GERD-Q total score of less than 8. This assessment applied only to participants who continued treatment beyond the initial 4-week period.
8 weeks
Time to Complete Symptom Response
Time Frame: Up to 8 weeks
Time to complete response was defined as the number of days from first dose of study medication to the first occurrence of complete disappearance of heartburn and/or acid regurgitation for seven consecutive days, based on participant diary records.
Up to 8 weeks
Proportion of Participants Without Major GERD Symptoms
Time Frame: Up to 8 weeks
The proportion of participants without major GERD symptoms (heartburn and/or acid regurgitation) during predefined periods, including the first 7 days, 4 weeks, and 8 weeks after initiation of treatment, as recorded in participant diaries.
Up to 8 weeks
Proportion of Days Free of Major GERD Symptoms
Time Frame: Up to 8 weeks
The proportion of days without heartburn and/or acid regurgitation during the first 7 days, 4 weeks, and 8 weeks after treatment initiation, including daytime, nighttime, and combined daytime/nighttime periods, based on participant diary entries.
Up to 8 weeks
Change From Baseline in GERD-Q Score
Time Frame: Baseline to up to 8 weeks
Change from baseline in GERD-Q total score and symptom frequency at Days 7, Week 4, and Week 8, assessing improvement in reflux-related symptoms over time.
Baseline to up to 8 weeks
Change From Baseline in GERD-Health-Related Quality of Life (GERD-HRQL)
Time Frame: Baseline to up to 8 weeks
Change from baseline in GERD-HRQL total score at Days 7, Week 4, and Week 8, evaluating treatment effects on health-related quality of life associated with GERD symptoms.
Baseline to up to 8 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants Without Nocturnal GERD Symptoms
Time Frame: Up to 8 weeks
The proportion of participants who were not awakened from sleep due to heartburn or acid regurgitation during predefined periods after initiation of study treatment, as recorded in participant diaries.
Up to 8 weeks
Proportion of Participants With Relief of Chronic Cough
Time Frame: Up to 8 weeks
The proportion of participants who experienced relief of chronic cough symptoms during predefined periods after initiation of study treatment, based on participant diary assessments.
Up to 8 weeks
Proportion of Participants With Relief of Throat Irritation Sensation
Time Frame: Up to 8 weeks
The proportion of participants who experienced relief of throat irritation or foreign body sensation during predefined periods after initiation of study treatment, as recorded in participant diaries.
Up to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Collaborators

Daewoong Pharmaceutical Co. LTD.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 23, 2024

Primary Completion (Actual)

October 10, 2024

Study Completion (Actual)

December 13, 2024

Study Registration Dates

First Submitted

December 17, 2025

First Submitted That Met QC Criteria

December 26, 2025

First Posted (Actual)

January 8, 2026

Study Record Updates

Last Update Posted (Actual)

January 8, 2026

Last Update Submitted That Met QC Criteria

December 26, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DW_DWP1401262001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared because the study protocol and informed consent did not include provisions for data sharing beyond the study investigators. In addition, the data contain sensitive participant information, and sharing IPD is restricted to protect participant confidentiality and comply with local regulations and institutional policies.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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