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COMPLETED

NCT07326904

PHASE3

Study Comparing Fexuprazan and Esomeprazole in Patients With Gastroesophageal Reflux Disease

Sponsor: Indonesia University

View on ClinicalTrials.gov

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

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)

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

145

Start Date

2024-08-28

Completion Date

2024-12-13

Last Updated

2026-08-24

Healthy Volunteers

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.

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

Locations (3)

Menteng Mitra Afia Jakarta Hospital

Jakarta Pusat, DKI Jakarta, Indonesia

RS Islam Jakarta Cempaka Putih