Clinical trial: Inhibition of Gastric Acid is the Key to Satisfactory Relief of Symptoms With Esomeprazole in NUD Patients (NCT00222131)

Eligibility criteria:
Inclusion criteria:

        A. Males and females of age 18-55. B. A diagnosis of epigastric pain/discomfort (located in
        the upper abdomen) rated by the patient as moderate to severe in intensity (on a four-point
        categorical scale), which has been present at least 3 times per week for 12 weeks,
        unrelated to exercise.

        C. Patients may have other symptoms of NUD including heartburn, regurgitation, bloating
        (abdominal distension), early satiety (feeling of fullness), belching (burping), or nausea;
        however, the dominant symptom must be epigastric pain/discomfort.

        D. Capable of and willing to give informed consent and comply with all study requirements.

        Exclusion criteria:

        A. H. pylori positive serology. B. Regular use of NSAIDs or more than 100 mg of aspirin. C.
        Patients requiring chronic treatment with any medication inducing GI symptoms (e.g.,
        certain antibiotics, codeine, etc.).

        D. History or presence of endoscopic/radiological evidence of esophagitis. E. History or
        presence of chronic gastric or duodenal ulcer. F. History or presence of duodenal erosions.
        G. History or previous upper GI surgery. H. Presence of concomitant symptoms of irritable
        bowel syndrome (IBS) as assessed by three or more of the Manning or Rome criteria.

        I. History or presence of other known organic disease that might explain the dyspepsia
        symptoms (e.g., symptomatic gallstones).

        J. Pregnancy or lactation. K. Inadequate contraception. L. Regular consumption of greater
        than 2 fluid ounces of beverage alcohol (corresponding to 2 cocktails or 40 fluid ounces of
        beer or 16 fluid ounces of wine) per day.

        M. History of substance abuse. N. Unwillingness or expected inability to tolerate absence
        of antisecretory medications (antacids, H2 receptor antagonists or Proton pump inhibitors
        (PPIs) or other GI pharmacotherapy for a period of time of study protocol (16 weeks
        maximum).
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 55 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