Clinical trial: The Effect of Dexrabeprazole on Intragastric and Intraesophageal Acidity (NCT02689999)

Eligibility criteria:
Inclusion Criteria:

          -  Diagnosis of gastroesophageal reflux disease (GERD) in presence of pyrosis and/or
             regurgitation occurs once a week or more.

          -  Esophagitis stage A-B according to Los Angeles classification,

          -  Major symptom should be gastroesophageal reflux disease (GERD) in presence of
             overlapping symptoms,

          -  Age range should be 18-70 years,

          -  BMI should be 18-33 kg/m2,

          -  Presence of sufficient gastric acidity: Cases which intragastric ph > 4 value is under
             25% according to dual multichannel intraluminal impedance-pH MII monitoring performed
             before study initiation,

          -  Pathologic intraesophageal acid exposure; DeMeester score > 14.75 and/or ph < 4 value
             > 4% (according to at 21 hour measurement at least),

          -  Helicobacter pylori should be negative according to biopsy in gastrointestinal system
             (GIS) endoscopy performed in last 12 months before study initiation; if biopsy not
             performed in endoscopy, stool antigen test or urease breath test should be performed
             and Helicobacter pylori should be negative.

        Exclusion Criteria:

          -  Presence of food in stomach in gastrointestinal system (GIS) endoscopy performed in
             last 12 months before study initiation, all types of gastrointestinal system (GIS)
             pathology such as Barret stricture, stomach channel obstruction, malignity,
             gastrointestinal system (GIS) bleeding and cases with > 3 cm Hiatus hernia.

          -  Presence of severe chronic comorbid diseases; uncontrolled or insulin-dependent
             diabetes mellitus (IDDM), symptomatic gallbladder stone (cases who are asymptomatic
             and are not undergo cholecystitis and whose stone is 3 cm or polyp is smaller than 1
             cm may be included), active or unhealed stomach or duodenum ulcer, Zollinger-Ellison
             syndrome, primary esophagus motility disorders, pancreatitis, inflammatory bowel
             disease, chronic liver disease, severe liver disease, uncontrolled renal impairment,
             presence of cancer except non-melanoma skin cancer, heart failure, cerebrovascular
             disease, epilepsy,

          -  Major psychiatric disease,

          -  Alcoholism or cases take narcotics,

          -  Pathologic laboratory test; hemogram, sedimentation, C-reactive protein (CRP), thyroid
             function tests, liver enzymes,

          -  Malabsorption that may affect drug absorption,

          -  Immunosuppressive and cortisone taking cases,

          -  Pregnancy or positive pregnancy test and lactating women,

          -  Cases taking all types of drugs which may affect gastrointestinal system motility or
             acid release,

          -  Cases undergo abdominal operation; hysterectomy, abdominal hernia operation,
             caesarean, appendectomies may be included but all types of cholecystectomy will be
             excluded.

          -  Cases taking a proton pomp inhibitor (PPI) and H2 blocker for last seven days and
             prokinetic drug for last three days,

          -  Condition that taking drugs need stomach acid for optimal absorption; such as
             ketoconazole, iron salts, digoxin, ampicillin esters, anticoagulants, antineoplastic
             agents.

          -  Cases who must take prostaglandin analogs,

          -  Cases who must take non-steroidal anti-inflammatory drug (NSAID) during study,

          -  Cases taking antidepressants,

          -  Cases who refuse to sign informed consent,

          -  Hypersensitivity to study drug.
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 70 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