Clinical trial: Effectiveness of Vonoprazan vs Omeprazole as Empiric Therapy for Gastroesophageal Reflux Disease (GERD) Patients Without Alarm Features (NCT04028466)

Eligibility criteria:
Inclusion Criteria:

          -  All Adult patients with clinically diagnosed with Gastroesophageal Reflux Disease
             (GERD) without alarm features (heartburn and acid regurgitation)

          -  Age more than 18 years at the time of written consent

          -  Those who provide written consent with their own free will

          -  Both treatment naïve and treatment experienced patients will be included. Treatment
             experienced patients should not be taking any proton pump inhibitors for 2 weeks to
             allow for washout period.

        Exclusion Criteria:

          -  Patients that have alarm features as defined by the Philippines Guidelines for GERD
             (dysphagia, odynophagia, weight loss, anemia, hematemesis, family history of
             esophageal adenocarcinoma, nocturnal choking, abdominal mass, recurrent/frequent
             vomiting, chest pain)

          -  Patients with atypical GERD symptoms (cough, laryngitis, chest pain, etc.)

          -  Patients already taking proton pump inhibitors for the past 2 weeks

          -  Patients who scored less than 8 on the FSSG questionnaire

          -  Patients who have undergone gastroesophageal surgery

          -  Patients who are poorly compliant to medications

          -  allergy to PPI or vonoprazan

          -  With serious comorbidities, such as but not limited to: heart failure, renal failure,
             malignancy or hepatic failure

          -  Pregnant, breastfeeding or possibly pregnant

          -  Patients that would not provide consent

          -  Patients who are unable to complete the FSSG Questionnaire independently

          -  Patients who are unable to follow up at designated periods

          -  Patients taking rilpivirine or atazanavir.

          -  Patients with elevated baseline liver function tests (more than twice the upper limit
             of normal)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 48-year-old man comes to the office complaining of heartburn and acid reflux.  He has taken over-the-counter antacids but sees no relief.  Other medical history is unremarkable.  The patient does not use tobacco, alcohol, or illicit drugs.  Vital signs are within normal limits.  BMI is 31 kg/m2.  Physical examination is  positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart.  A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus.

Patient description (patient's own words): I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm!

Does the patient match the trial criteria? Entailment