Clinical trial: Proton Pump Inhibitor Empirical Treatment in Management of Outpatients With Gastroesophageal Reflux Disease. (NCT02606851)

Eligibility criteria:
Inclusion Criteria:

          -  Female or male, and any race, Age ≥ 18 years and≤ 65 outpatients.

          -  Gastroenterologists already prescribe PPI standard dose bid as empirical treatment.

          -  GerdQ≥8

          -  The subject will not have endoscopy within 4 weeks after enrolment.

          -  Ability to provide informed consent, adhere to the study visit schedule, and complete
             all study assessments and complete the patient diary by his/herself.

        Exclusion Criteria:

          -  If participating in any interventional clinical trial.

          -  Patient with alarm symptom of oncology(weight loss, recurrent dysphagia, anemia,
             hematemesis, melena).

          -  Continuous application of nonsteroidal anti-inflammation drugs or acid suppressive
             drug within 2 weeks before screening.

          -  The need for H2-receptor antagonists (H2RA) including cimetidine, ranitidine and
             famotidine or sucralfate, antacids, traditional Chinese medicine and prokinetics
             during the upcoming 4 weeks (study duration).

          -  Previous gastroesophageal surgery.

          -  Upper gastrointestinal malignancy, achalasia, and esophageal spasm or stricture.

          -  Peptic ulcer

          -  Diabetes

          -  Cerebral vascular disease

          -  Zollinger-Ellison syndrome

          -  Scleroderma

          -  Hiatus hernia women

          -  Pregnant or lactating women

          -  Any other subjects were not suitable to this study in the opinion of the investigator.
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.
Subject must be at most 65 Years

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