Clinical trial: To Assess the Efficacy of Esomeprazole 40 mg Once Daily in Subjects Who Still Had Heartburn After Receiving Rabeprazole (NCT01249651)

Eligibility criteria:
Inclusion Criteria:

          -  Male or female aged 20 years or more

          -  Documented history of reflux esophagitis verified by endoscopy in the past, including
             the grade of Los Angeles (LA) classification (Lundell LR et al 1999) before treatment

          -  Ongoing (until date of Visit 1) treatment with rabeprazole 20 mg, given once daily,
             for a period of 4 to 8 weeks. The subject must take Rabeprazole at least 4 days a week
             in the past 7 days prior to Visit 1.

          -  Persisting symptoms of heartburn during the past 7 days prior to Visit 1, judged by
             the investigator(s) as follows: At least 2 days with moderate (i.e. discomfort
             sufficient to cause interference with normal activities) to severe symptoms (i.e.
             incapacitating, with inability to perform normal activities) OR At least 4 days with
             symptoms including mild ones (i.e. awareness of sign or symptom, but easily
             tolerated).

          -  The subject needs to be able to understand and read the official languages of the
             country.

        Exclusion Criteria:

          -  Use of other PPIs and/or H2RA during rabeprazole treatment

          -  Previous use of esomeprazole 40 mg during the 12 weeks before enrolment

          -  Current or historical evidence of gastrointestinal pathology

          -  History, signs or symptoms of clinically significant or uncontrolled cardiovascular,
             pulmonary, renal, endocrine, hematologic, neurologic, psychiatric pancreatic or
             hepatic disease as judged by the investigator to interfere with the conduct of the
             study, the interpretation of study results, subject compliance, or the health of the
             subject during the study.

          -  Documented upper gastrointestinal surgery such as gastric resection, vagotomy and/or
             pyloroplasty, hiatus hernia surgery or fundoplication. Note: endoscopic polypectomy,
             endoscopic mucosal resection, endoscopic submucosal dissection or simple suturing of
             an ulcer are not exclusion criteria.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 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? Contradiction