CompletedPhase 3

Study Comparing Fexuprazan and Esomeprazole in Patients With Gastroesophageal Reflux Disease

Indonesia145 participantsStarted 2024-09-23

Plain-language 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

Who can participate

Age range18 Years – 60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

What they're measuring

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

Timeframe: 4 weeks

Trial details

NCT IDNCT07326904

SponsorIndonesia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-10