Study Comparing Fexuprazan and Esomeprazole in Patients With Gastroesophageal Reflux Disease
NCT ID: NCT07326904
Last Updated: 2026-01-08
Study Results
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Basic Information
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COMPLETED
PHASE3
145 participants
INTERVENTIONAL
2024-09-23
2024-12-13
Brief Summary
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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
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
No
Sponsors
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Daewoong Pharmaceutical Co. LTD.
INDUSTRY
Indonesia University
OTHER
Responsible Party
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Ari Fahrial Syam
Consultant Gastroenterologist, Department of Internal Medicine
Principal Investigators
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Ari Fahrial Syam, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Internal Medicine, Faculty of Medicine, Universitas Indonesia / RSUPN Dr. Cipto Mangunkusumo
Locations
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Menteng Mitra Afia Jakarta Hospital
Jakarta Pusat, DKI Jakarta, Indonesia
Islam Cempaka Putih Jakarta Hospital
Jakarta Pusat, DKI Jakarta, Indonesia
University of Indonesia Hospital
Depok, West Java, Indonesia
Countries
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References
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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.
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.
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.
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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DW_DWP1401262001
Identifier Type: -
Identifier Source: org_study_id
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