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)
Abstract
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
Conditions: Gastro Oesophageal Reflux Disease.
Primary outcome: Proportion of Participants With Symptom Relief at Week 4 (GERD-Q Score <8).
Enrollment: 145 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 145 participants or records.
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