New GERD drug fexuprazan tested against standard treatment in 145 patients
NCT ID NCT07326904
First seen Jun 25, 2026 · Last updated Aug 25, 2026 · Updated 3 times
Summary
This study tested whether fexuprazan, a new drug, can relieve heartburn and acid reflux as well as the commonly used esomeprazole. 145 adults with GERD took either fexuprazan or esomeprazole once daily for 4 weeks, with an option to continue for another 4 weeks if symptoms didn't improve. Researchers measured symptom relief using a standard questionnaire and monitored safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- fexuprazan
- What this could lead to
- If fexuprazan works as well as esomeprazole, it could offer another treatment option for people with GERD to ease heartburn and acid reflux.
- What could go wrong
- This is a completed phase 3 trial, but results are not yet published. It only included 145 adults aged 18-60, so findings may not apply to older people or those with severe GERD.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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145 people
The number who actually took part.
- Started
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Aug 2024
- Finished
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Dec 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Menteng Mitra Afia Jakarta Hospital
Jakarta Pusat, DKI Jakarta, 10340, Indonesia
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RS Islam Jakarta Cempaka Putih
Jakarta Pusat, DKI Jakarta, 10510, Indonesia
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RS Universitas Indonesia
Depok, West Java, 16424, Indonesia
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