Clinical trial: The Clinical Significance of Acid Rebound in Functional Dyspepsia (NCT01373970)

Eligibility criteria:
Inclusion Criteria:

          -  Symptoms indicating dyspepsia, including:

               -  Epigastric pain or epigastric discomfort

               -  Bothersome postprandial fullness

               -  Early satiation

               -  Epigastric burning

          -  Access to internet

        Exclusion Criteria:

          -  Daily use of PPI or H2-receptor antagonists in more than 28 days within the last 120
             days OR more than two days within the last 28 days OR more than five non-consecutive
             days within the last 28 days.

          -  Mild heartburn or regurgitation more than once per week

          -  Moderate or severe heartburn or regurgitation at least once per week

          -  Complications to GERD (esophagitis, stricture or Barrett's esophagus) prior to
             enrolment or at screening

          -  Abnormal findings at upper endoscopy necessitating treatment

          -  Abnormal pH-monitoring prior to enrolment or at screening (pH <4 in ≥5.5 % of the time
             on "worst day" of 48-h monitoring)

               -  Excludes data from analysis regarding primary endpoint (see summary)

          -  Previous surgery on esophagus, stomach or duodenum

          -  Regular use of NSAIDs through the last six months

          -  Potential language problems in understanding information and registering symptoms

          -  Pregnancy or breast feeding

          -  Other diseases which can interfere with the symptom registration (severe congestive
             heart disease, malignant disease, schizophrenia ect.)

          -  Abuse of alcohol/narcotics

          -  Allergy/intolerance to gelatine or lactose used in placebo

          -  Patients with pacemaker, Implantable Cardioverter Defibrillator or Implantable
             Neurostimulator
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? Contradiction