Clinical trial: Esomeprazole Plus Alginate vs. Esomeprazole Alone for Treatment of Nighttime Reflux Symptom and Sleep Disturbances (NCT02277886)

Eligibility criteria:
Inclusion Criteria:

          -  Out -patients with age of 20-80 years old (inclusive) in Taiwan of both genders

          -  Patients who had been previously diagnosed as erosive GERD (i.e. grade A~D according
             to the modified Los-Angeles Classification. Endoscopic examination results within 21
             days before randomization visit (V2) are acceptable.

          -  Patients with history of heartburn (or regurgitation) for ≥ 3 months before entering
             study

          -  Patients with history of GERD-related sleep disturbances for ≥ 1 month before entering
             study

          -  Patients with nighttime heartburn (or regurgitation) graded as moderate, or severe, on
             ≥ 3 nights in the last 7 days of screening period

          -  Patients with GERD-related sleep disturbances on ≥ 3 nights in the last 7 days of
             screening period

          -  Patients with the global PSQI score >5

          -  Patients have signed the informed consent form

        Exclusion Criteria:

          -  Patients with non-erosive GERD, Barrett's esophagus or esophageal stricture

          -  Patients with any conditions other than GERD that could be the primary cause of sleep
             disturbance (e.g. sleep apnoea, obstructed airway, severe depression, severe anxiety,
             panic attacks, chronic obstructive pulmonary disease requiring oxygen therapy)

          -  Patients with active esophageal, gastric or duodenal ulcers

          -  Patients with history of esophageal, gastric or duodenal surgery

          -  Patients with active cancers of any kind

          -  Female patients who are pregnant or lactating

          -  Patients who were allergy to any of the study drugs

          -  Patients taken a proton pump inhibitor (PPI) within 7 days, or any prokinetic agent,
             H2-blocker, alginate preparations or antacid within 2 days before screening

          -  Patients with a history of drug addiction or alcohol abuse within the past 12 months

          -  Patients with any other conditions or diseases that investigator considers it is not
             appropriate to enter the study
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.
Subject must be at most 80 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? Contradiction