Gastro Oesophageal Reflux DiseasePhase 3NCT07326904

Study Comparing Fexuprazan and Esomeprazole in Patients With Gastroesophageal Reflux Disease

A Phase 3 study testing Fexuprazan and Esomeprazole in people with Gastro Oesophageal Reflux Disease, run by Universitas Indonesia at 3 sites in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Gastro Oesophageal Reflux Disease
What is being tested?: Fexuprazan and Esomeprazole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 145 participants
Where: 3 sitesIndonesia
Study dates: 28 Aug 2024to 13 Dec 2024
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Show all 23Show fewer

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

Trial locations and contacts

3 sites in 1 country.

Indonesia3 sites

RS Universitas Indonesia
Depok, West Java, 16424
Menteng Mitra Afia Jakarta Hospital
Jakarta Pusat, DKI Jakarta, 10340
RS Islam Jakarta Cempaka Putih
Jakarta Pusat, DKI Jakarta, 10510

Other trials in Indonesia

About this study

Official title: 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 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

Read the 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.

Conditions: Gastro Oesophageal Reflux Disease
Being tested: Fexuprazan, Esomeprazole
Keywords: Gastroesophageal reflux disease (GERD), fexuprazan, esomeprazole, Potassium-competitive acid blockers (P-CABs), Proton pump inhibitors (PPIs), Randomized trial
Medical subject headings: Gastroesophageal Reflux

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FexuprazanDrug
Also called Fexuclue, DWP14012
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.
EsomeprazoleDrug
Also called Nexium
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.

Study groups in NCT07326904
Study group	Role	What they receive
Fexuprazan 40 mg	Experimental	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. Receives: Drug: Fexuprazan
Esomeprazole 40 mg	Active comparator	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. Receives: Drug: Esomeprazole

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of Participants With Symptom Relief at Week 4 (GERD-Q Score <8)
Symptom relief was assessed using the Gastroesophageal Reflux Disease Questionnaire (GERD-Q). The GERD-Q total score ranges from a minimum of 0 to a maximum of 18, where higher scores indicate a worse outcome (greater severity and higher likelihood of GERD). The primary outcome was defined as the proportion of participants with a GERD-Q total score <8 at Week 4, indicating adequate relief of GERD symptoms.
Measured: 4 weeks

Secondary outcomes (6)

Proportion of Participants With Symptom Relief at Week 8 (GERD-Q Score <8)
The proportion of participants who achieved symptom relief at Week 8, defined as a total score of less than 8 on the Gastroesophageal Reflux Disease Questionnaire (GERD-Q). The GERD-Q total score ranges from a minimum of 0 to a maximum of 18, where higher scores indicate a worse outcome (greater symptom severity). This assessment applied only to participants who continued treatment beyond the initial 4-week period.
Measured: 8 weeks
Time to Complete Symptom Response After First Dose
Complete response was defined as the absence of heartburn and/or acid regurgitation symptoms for 7 consecutive days based on patient diaries. Time to complete response was measured in days from the first dose to the first day of the 7-day symptom-free period. Analysis included all subjects using time-to-event methods.
Measured: From first dose until achievement of complete response, up to 8 weeks
Number of Participants Without Major GERD Symptoms
The number 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.
Measured: Up to 8 weeks
Percentage of Days Free of Major GERD Symptoms
The percentage of days without heartburn and/or acid regurgitation per participant during the first 7 days, 4 weeks, and 8 weeks after treatment initiation. This includes daytime, nighttime, and combined daytime/nighttime periods based on participant diary entries, analyzed and reported as the mean percentage of symptom-free days
Measured: Up to 8 weeks
Change From Baseline in GERD-Q Total Score
Change from baseline in the Gastroesophageal Reflux Disease Questionnaire (GERD-Q) total score. The GERD-Q is a 6-item scale used to evaluate the frequency of GERD symptoms. Total scores range from a minimum of 0 to a maximum of 18, where higher scores indicate greater symptom severity (a worse outcome).
Measured: Baseline up to 8 weeks (Evaluated at 7 days, 4 weeks, and 8 weeks)
Change From Baseline in GERD-Health-Related Quality of Life (GERD-HRQL) Total Score
Change from baseline in the Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) total score. The GERD-HRQL is a 10-item instrument used to assess the impact of symptoms on daily life. Total scores range from a minimum of 0 to a maximum of 50, where higher scores indicate worse health-related quality of life (a worse outcome).
Measured: Baseline to up to 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Aug 202413 Dec 2024

First posted8 Jan 2026
Study start28 Aug 2024
Primary completion12 Nov 2024
Study completion13 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (26)Papers the sponsor has linked to this study.
Other trials for Gastro Oesophageal Reflux DiseaseStudies of the same condition, open and under way.
More trials run by Universitas IndonesiaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: This study used a parallel-group interventional design. Eligible participants were randomized in a 1:1 ratio to receive either fexuprazan 40 mg or esomeprazole 40 mg. Each participant remained in the assigned treatment group throughout the study duration. All participants received their assigned intervention for an initial treatment period of 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with the same assigned intervention for an additional 4 weeks, for a maximum treatment duration of 8 weeks. No crossover between treatment groups occurred at any time during the study. Efficacy and safety outcomes were evaluated in parallel between the two treatment groups over the course of the study.
Masking: None (open label)
Enrolment: 145 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07326904
Sponsor's protocol ID: DW_DWP1401262001
Status last verified: May 2026
First submitted: 17 Dec 2025
Last updated: 24 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: 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.

Publications

Yang AY, Yoo H, Shin W, Lee YS, Lee H, Kim SE, Kim A. Size-reduced fexuprazan 20 mg demonstrated the optimal bioavailability and bioequivalence with the reference formulation. Transl Clin Pharmacol. 2023 Mar;31(1):40-48. doi: 10.12793/tcp.2023.31.e3. Epub 2023 Mar 22.
PubMed 37034124
Laine L, Sharma P, Mulford DJ, Hunt B, Leifke E, Smith N, Howden CW. Pharmacodynamics and Pharmacokinetics of the Potassium-Competitive Acid Blocker Vonoprazan and the Proton Pump Inhibitor Lansoprazole in US Subjects. Am J Gastroenterol. 2022 Jul 1;117(7):1158-1161. doi: 10.14309/ajg.0000000000001735. Epub 2022 Mar 16.
PubMed 35294415
Shin W, Yang AY, Park H, Lee H, Yoo H, Kim A. A Comparative Pharmacokinetic Study of Fexuprazan 10 mg: Demonstrating Bioequivalence with the Reference Formulation and Evaluating Steady State. Pharmaceuticals (Basel). 2023 Aug 11;16(8):1141. doi: 10.3390/ph16081141.
PubMed 37631056
Kim GH, Choi MG, Kim JI, Lee ST, Chun HJ, Lee KL, Choi SC, Jang JY, Lee YC, Kim JG, Kim KB, Shim KN, Sohn CI, Kim SK, Kim SG, Jang JS, Kim N, Jung HY, Park H, Huh KC, Lee KJ, Hong SJ, Baek S, Han JJ, Lee OY. Efficacy and Safety of Fexuprazan in Patients with Acute or Chronic Gastritis. Gut Liver. 2023 Nov 15;17(6):884-893. doi: 10.5009/gnl220457. Epub 2023 Feb 15.
PubMed 36789577
Kim SI, Lee YC, Cha W, Jung AR, Jang JY, Choi JS, Lee DK, Lee HH, Kwon MS, Lee YS, Eun YG. Efficacy and safety of fexuprazan in patients with symptoms and signs of laryngopharyngeal reflux disease: a randomized clinical trial. Eur Arch Otorhinolaryngol. 2024 Nov;281(11):5873-5883. doi: 10.1007/s00405-024-08877-6. Epub 2024 Aug 8.
PubMed 39115573
Zhuang Q, Liao A, He Q, Liu C, Zheng C, Li X, Liu Y, Wang B, Liu S, Zhang Y, Lin R, Chen H, Deng M, Tang Y, He C, Dai W, Tang H, Gong L, Li L, Xu B, Yang C, Zhou B, Su D, Guo Q, Li B, Zhou Y, Wang X, Fei S, Wu H, Wei S, Peng Z, Wang J, Li Y, Wang H, Deng T, Ding S, Li F, Chen M, Xiao Y. The efficacy and safety of fexuprazan in treating erosive esophagitis: a phase III, randomized, double-blind, multicenter study. J Gastroenterol Hepatol. 2024 Apr;39(4):658-666. doi: 10.1111/jgh.16471. Epub 2024 Jan 22.
PubMed 38251791
Kang N, Kang MG, Lee SE, Kang SY, Jo EJ, Lee JH, Kim SH, Bahn JW, Lee BJ, Song WJ. Efficacy and Safety of Fexuprazan Versus Esomeprazole for Gastroesophageal Reflux Disease-Related Chronic Cough: A Randomized, Double-Blind, Active-Controlled Exploratory Trial. Lung. 2025 Apr 29;203(1):59. doi: 10.1007/s00408-025-00815-5.
PubMed 40299084
Won H, Kim E, Chae J, Lee H, Cho JY, Jang IJ, Chung JY, Kim MG, Lee S. Pharmacokinetic interactions between fexuprazan, a potassium-competitive acid blocker, and nonsteroidal anti-inflammatory drugs in healthy males. Clin Transl Sci. 2024 May;17(5):e13798. doi: 10.1111/cts.13798.
PubMed 38700290
Oh J, Yang E, Jang IJ, Lee H, Yoo H, Chung JY, Lee S, Oh J. Pharmacodynamic and Pharmacokinetic Drug Interactions between Fexuprazan, a Novel Potassium-Competitive Inhibitor, and Aspirin, in Healthy Subjects. Pharmaceutics. 2023 Feb 7;15(2):549. doi: 10.3390/pharmaceutics15020549.
PubMed 36839870
Hwang JG, Jeon I, Park SA, Lee A, Yu KS, Jang IJ, Lee S. Pharmacodynamics and pharmacokinetics of DWP14012 (fexuprazan) in healthy subjects with different ethnicities. Aliment Pharmacol Ther. 2020 Dec;52(11-12):1648-1657. doi: 10.1111/apt.16131. Epub 2020 Oct 27.
PubMed 33111337
Sunwoo J, Oh J, Moon SJ, Ji SC, Lee SH, Yu KS, Kim HS, Lee A, Jang IJ. Safety, tolerability, pharmacodynamics and pharmacokinetics of DWP14012, a novel potassium-competitive acid blocker, in healthy male subjects. Aliment Pharmacol Ther. 2018 Jul;48(2):206-218. doi: 10.1111/apt.14818. Epub 2018 Jun 4.
PubMed 29863280
Lee SP, Sung IK, Lee OY, Choi MG, Huh KC, Jang JY, Chun HJ, Kwon JG, Kim GH, Kim N, Rhee PL, Kim SG, Jung HY, Lee JS, Lee YC, Jung HK, Kim JG, Kim SK, Sohn CI. Randomized Multicenter Study to Evaluate the Efficacy and Safety of Fexuprazan According to the Timing of Dosing in Patients With Erosive Esophagitis. J Neurogastroenterol Motil. 2025 Jan 31;31(1):86-94. doi: 10.5056/jnm24032. Epub 2024 Dec 13.
PubMed 39667898
Hafiz RA, Wong C, Paynter S, David M, Peeters G. The Risk of Community-Acquired Enteric Infection in Proton Pump Inhibitor Therapy: Systematic Review and Meta-analysis. Ann Pharmacother. 2018 Jul;52(7):613-622. doi: 10.1177/1060028018760569. Epub 2018 Feb 18.
PubMed 29457492
Strand DS, Kim D, Peura DA. 25 Years of Proton Pump Inhibitors: A Comprehensive Review. Gut Liver. 2017 Jan 15;11(1):27-37. doi: 10.5009/gnl15502.
PubMed 27840364
Rettura F, Bronzini F, Campigotto M, Lambiase C, Pancetti A, Berti G, Marchi S, de Bortoli N, Zerbib F, Savarino E, Bellini M. Refractory Gastroesophageal Reflux Disease: A Management Update. Front Med (Lausanne). 2021 Nov 1;8:765061. doi: 10.3389/fmed.2021.765061. eCollection 2021.
PubMed 34790683

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Gastro Oesophageal Reflux Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT07326904
Acronym / sponsor ID: DW_DWP1401262001
Conditions: Gastro Oesophageal Reflux Disease
Keywords: Gastroesophageal reflux disease (GERD), fexuprazan, esomeprazole, Potassium-competitive acid blockers (P-CABs), Proton pump inhibitors (PPIs), Randomized trial
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 145 participants (actual)
Lead sponsor: Universitas IndonesiaUniversity, hospital or other
Collaborators: Daewoong Pharmaceutical Co. LTD.
Study start: 28 Aug 2024 (actual)
Primary completion: 12 Nov 2024 (actual)
Study completion: 13 Dec 2024 (actual)
First posted: 8 Jan 2026 (actual)
Results: Posted 24 Aug 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: This study used a parallel-group interventional design. Eligible participants were randomized in a 1:1 ratio to receive either fexuprazan 40 mg or esomeprazole 40 mg. Each participant remained in the assigned treatment group throughout the study duration. All participants received their assigned intervention for an initial treatment period of 4 weeks. Participants who did not achieve adequate symptom relief after the initial treatment period continued treatment with the same assigned intervention for an additional 4 weeks, for a maximum treatment duration of 8 weeks. No crossover between treatment groups occurred at any time during the study. Efficacy and safety outcomes were evaluated in parallel between the two treatment groups over the course of the study.

Arm	Type	Receives
Fexuprazan 40 mg	Experimental	Drug: FexuprazanParticipants 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.
Esomeprazole 40 mg	Active comparator	Drug: EsomeprazoleParticipants 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.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (8 listed)

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:
Able to understand the study procedures and complete questionnaires and a daily symptom diary

Key exclusion criteria (23 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FexuprazanAlso: Fexuclue, DWP14012Fexuprazan 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	Fexuprazan 40 mg
EsomeprazoleAlso: NexiumEsomeprazole 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.	Drug	Esomeprazole 40 mg

Primary outcome

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 GERD-Q total score ranges from a minimum of 0 to a maximum of 18, where higher scores indicate a worse outcome (greater severity and higher likelihood of GERD). The primary outcome was defined as the proportion of participants with a GERD-Q total score <8 at Week 4, indicating adequate relief of GERD symptoms.

6 secondary outcomes

Proportion of Participants With Symptom Relief at Week 8 (GERD-Q Score <8)
Time frame: 8 weeks
Time to Complete Symptom Response After First Dose
Time frame: From first dose until achievement of complete response, up to 8 weeks
Number of Participants Without Major GERD Symptoms
Time frame: Up to 8 weeks
Percentage of Days Free of Major GERD Symptoms
Time frame: Up to 8 weeks
Change From Baseline in GERD-Q Total Score
Time frame: Baseline up to 8 weeks (Evaluated at 7 days, 4 weeks, and 8 weeks)
Change From Baseline in GERD-Health-Related Quality of Life (GERD-HRQL) Total Score
Time frame: Baseline to up to 8 weeks

Results and safety

Results posted to the registry on 24 Aug 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fexuprazan 40 mg	67	67
Esomeprazole 40 mg	67	67

Primary outcome: Proportion of Participants With Symptom Relief at Week 4 (GERD-Q Score <8)

Time frame: 4 weeks. Number (95% Confidence Interval). Unit: Proportion of participants

Measure	Fexuprazan 40 mg n = 66	Esomeprazole 40 mg n = 67
Value	0.7879 (0.670 to 0.879)	0.7910 (0.674 to 0.881)

Population analysed: The primary efficacy analysis was conducted in the Full Analysis Set (FAS), defined as all randomized participants who received at least one dose of study medication and had a post-baseline GERD-Q assessment.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 8 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fexuprazan 40 mg	0 of 67 (0%)	42 of 67 (62.7%)	0 of 67
Esomeprazole 40 mg	0 of 67 (0%)	38 of 67 (56.7%)	0 of 67

Limitations and caveats (from the sponsor): Open-label design may introduce reporting bias for subjective symptoms. As an investigator-initiated trial, the scope was narrower than large registration trials. Use of Last Observation Carried Forward (LOCF) for missing efficacy data might not accurately reflect outcomes post-dropout. Finally, results from the specific geographic setting (Indonesia) may have limited generalizability to broader global populations.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 37034124Yang AY, Yoo H, Shin W, Lee YS, Lee H, Kim SE, Kim A. Size-reduced fexuprazan 20 mg demonstrated the optimal bioavailability and bioequivalence with the reference formulation. Transl Clin Pharmacol. 2023 Mar;31(1):40-48. doi: 10.12793/tcp.2023.31.e3. Epub 2023 Mar 22.
Background: PubMed 35294415Laine L, Sharma P, Mulford DJ, Hunt B, Leifke E, Smith N, Howden CW. Pharmacodynamics and Pharmacokinetics of the Potassium-Competitive Acid Blocker Vonoprazan and the Proton Pump Inhibitor Lansoprazole in US Subjects. Am J Gastroenterol. 2022 Jul 1;117(7):1158-1161. doi: 10.14309/ajg.0000000000001735. Epub 2022 Mar 16.
Background: PubMed 37631056Shin W, Yang AY, Park H, Lee H, Yoo H, Kim A. A Comparative Pharmacokinetic Study of Fexuprazan 10 mg: Demonstrating Bioequivalence with the Reference Formulation and Evaluating Steady State. Pharmaceuticals (Basel). 2023 Aug 11;16(8):1141. doi: 10.3390/ph16081141.
Background: PubMed 36789577Kim GH, Choi MG, Kim JI, Lee ST, Chun HJ, Lee KL, Choi SC, Jang JY, Lee YC, Kim JG, Kim KB, Shim KN, Sohn CI, Kim SK, Kim SG, Jang JS, Kim N, Jung HY, Park H, Huh KC, Lee KJ, Hong SJ, Baek S, Han JJ, Lee OY. Efficacy and Safety of Fexuprazan in Patients with Acute or Chronic Gastritis. Gut Liver. 2023 Nov 15;17(6):884-893. doi: 10.5009/gnl220457. Epub 2023 Feb 15.
Background: PubMed 39115573Kim SI, Lee YC, Cha W, Jung AR, Jang JY, Choi JS, Lee DK, Lee HH, Kwon MS, Lee YS, Eun YG. Efficacy and safety of fexuprazan in patients with symptoms and signs of laryngopharyngeal reflux disease: a randomized clinical trial. Eur Arch Otorhinolaryngol. 2024 Nov;281(11):5873-5883. doi: 10.1007/s00405-024-08877-6. Epub 2024 Aug 8.
Background: PubMed 38251791Zhuang Q, Liao A, He Q, Liu C, Zheng C, Li X, Liu Y, Wang B, Liu S, Zhang Y, Lin R, Chen H, Deng M, Tang Y, He C, Dai W, Tang H, Gong L, Li L, Xu B, Yang C, Zhou B, Su D, Guo Q, Li B, Zhou Y, Wang X, Fei S, Wu H, Wei S, Peng Z, Wang J, Li Y, Wang H, Deng T, Ding S, Li F, Chen M, Xiao Y. The efficacy and safety of fexuprazan in treating erosive esophagitis: a phase III, randomized, double-blind, multicenter study. J Gastroenterol Hepatol. 2024 Apr;39(4):658-666. doi: 10.1111/jgh.16471. Epub 2024 Jan 22.
Background: PubMed 40299084Kang N, Kang MG, Lee SE, Kang SY, Jo EJ, Lee JH, Kim SH, Bahn JW, Lee BJ, Song WJ. Efficacy and Safety of Fexuprazan Versus Esomeprazole for Gastroesophageal Reflux Disease-Related Chronic Cough: A Randomized, Double-Blind, Active-Controlled Exploratory Trial. Lung. 2025 Apr 29;203(1):59. doi: 10.1007/s00408-025-00815-5.
Background: PubMed 38700290Won H, Kim E, Chae J, Lee H, Cho JY, Jang IJ, Chung JY, Kim MG, Lee S. Pharmacokinetic interactions between fexuprazan, a potassium-competitive acid blocker, and nonsteroidal anti-inflammatory drugs in healthy males. Clin Transl Sci. 2024 May;17(5):e13798. doi: 10.1111/cts.13798.
Background: PubMed 36839870Oh J, Yang E, Jang IJ, Lee H, Yoo H, Chung JY, Lee S, Oh J. Pharmacodynamic and Pharmacokinetic Drug Interactions between Fexuprazan, a Novel Potassium-Competitive Inhibitor, and Aspirin, in Healthy Subjects. Pharmaceutics. 2023 Feb 7;15(2):549. doi: 10.3390/pharmaceutics15020549.
Background: PubMed 33111337Hwang JG, Jeon I, Park SA, Lee A, Yu KS, Jang IJ, Lee S. Pharmacodynamics and pharmacokinetics of DWP14012 (fexuprazan) in healthy subjects with different ethnicities. Aliment Pharmacol Ther. 2020 Dec;52(11-12):1648-1657. doi: 10.1111/apt.16131. Epub 2020 Oct 27.
Background: PubMed 29863280Sunwoo J, Oh J, Moon SJ, Ji SC, Lee SH, Yu KS, Kim HS, Lee A, Jang IJ. Safety, tolerability, pharmacodynamics and pharmacokinetics of DWP14012, a novel potassium-competitive acid blocker, in healthy male subjects. Aliment Pharmacol Ther. 2018 Jul;48(2):206-218. doi: 10.1111/apt.14818. Epub 2018 Jun 4.
Background: PubMed 39667898Lee SP, Sung IK, Lee OY, Choi MG, Huh KC, Jang JY, Chun HJ, Kwon JG, Kim GH, Kim N, Rhee PL, Kim SG, Jung HY, Lee JS, Lee YC, Jung HK, Kim JG, Kim SK, Sohn CI. Randomized Multicenter Study to Evaluate the Efficacy and Safety of Fexuprazan According to the Timing of Dosing in Patients With Erosive Esophagitis. J Neurogastroenterol Motil. 2025 Jan 31;31(1):86-94. doi: 10.5056/jnm24032. Epub 2024 Dec 13.
Individual participant dataSharing planned: No. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ari Fahrial Syam, MD, PhD study chair

RS Islam Jakarta Cempaka Putih

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fexuprazan and Esomeprazole in people with Gastro Oesophageal Reflux Disease, run by Universitas Indonesia at 3 sites in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Participants With Symptom Relief at Week 4 (GERD-Q Score <8) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07326904, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.