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)
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Indonesia University
- Enrollment
- 145
- Locations
- 6
- Primary Endpoint
- Proportion of Participants With Symptom Relief at Week 4 (GERD-Q Score <8)
Overview
Brief 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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Fexuprazan (Drug)
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.
Intervention: Esomeprazole (Drug)
Outcomes
Primary Outcomes
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 primary outcome was defined as the proportion of participants with a GERD-Q total score of less than 8 at Week 4, indicating adequate relief of GERD symptoms. The GERD-Q is a validated, patient-reported questionnaire that evaluates the frequency and severity of reflux-related symptoms, including heartburn and acid regurgitation.
Secondary Outcomes
- Proportion of Participants With Symptom Relief at Week 8 (GERD-Q Score <8)(8 weeks)
- Time to Complete Symptom Response(Up to 8 weeks)
- Proportion of Participants Without Major GERD Symptoms(Up to 8 weeks)
- Proportion of Days Free of Major GERD Symptoms(Up to 8 weeks)
- Change From Baseline in GERD-Q Score(Baseline to up to 8 weeks)
- Change From Baseline in GERD-Health-Related Quality of Life (GERD-HRQL)(Baseline to up to 8 weeks)
Investigators
Ari Fahrial Syam
Consultant Gastroenterologist, Department of Internal Medicine
Indonesia University