Clinical trial: Efficacy of TAK-438 Compared to Placebo in the Treatment of Non-Erosive Gastroesophageal Reflux Disease (NCT01474369)

Eligibility criteria:
Inclusion Criteria:

          1. Participants with grade N or M in the modified LA classification system confirmed by
             endoscopy at initiation of the pre-observation period (VISIT 1).

          2. Participants with repeated acid reflux symptoms (heartburn or regurgitation) for 2
             days or more in one week in the 3 weeks before initiation of initiation of the
             pre-observation period (VISIT 1).

          3. Participants with severity* of moderate or higher for acid reflux symptoms (heartburn
             or regurgitation) in the 3 weeks before initiation of the pre-observation period
             (VISIT 1)

             * Severity: No symptoms, very mild (symptoms present but often forgotten), mild (not
             so painful), moderate (rather painful), severe (painful) and very severe (painful
             enough to affect night time sleep or daily activities)

          4. Outpatients (hospitalization for testing possible)

        Exclusion Criteria:

          1. Participants with an esophagus-related complication [Barrett's esophagus (3 cm or
             more, LSBE), eosinophilic esophagitis, esophageal varices, scleroderma, viral or
             fungal infections, esophageal stenosis, etc.], or a history of radiotherapy or
             cryotherapy of the esophagus, a caustic or physiochemical trauma (esophageal
             sclerotherapy, etc.). However, participants with Barrett's esophagus (less than 3 cm,
             SSBE) or Schatzki's ring (mucosal tissue ring around inferior esophageal sphincter)
             are allowed to be included.

          2. Participants who have received surgery or treatment affecting gastroesophageal reflux
             (cardioplasty, dilation of esophageal stenosis [excluding Schatzki's ring], etc.), or
             who have a history of surgery of stomach or duodenum (excluding removal of benign
             polyp under endoscopy)

          3. Participants who have acute upper gastrointestinal bleeding, gastric ulcers (mucosal
             defects associated with white coating) or duodenal ulcers (mucosal defect with white
             coating) within 30 days before initiation of the pre-observation period (VISIT 1)
             However, participants with gastric or duodenal erosions are allowed to be included.

          4. Participants with acute gastritis or acute exacerbation of chronic gastritis as a
             complication

          5. Participants with a previous or current history of the Zollinger-Ellison syndrome or
             other gastric acid hypersecretion disorders

          6. Participants with a history of chest pain due to heart disease or with chest pains
             suspected of being caused by heart disease within one year before initiation of the
             pre-observation period (VISIT 1)
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