Clinical trial: A Study of E3810 With Pre- and Post-Treatment pH Monitoring in Patients With Non-Erosive Gastroesophageal Reflux Disease (NCT00165672)

Eligibility criteria:
Inclusion Criteria:

        The patients to be included will be outpatients who meet all of the following criteria. No
        specific gender is asked.

        <For the observation period>

          1. Patients who have "heartburn" 2 days a week or more during consecutive 3 weeks* prior
             to pre-observation screening. *If a day of screening and a day of starting observation
             (date of registration) are different, heartburn must continuously be present during
             the in-between period.

          2. Patients who meet both 1) and 2) below;

        1) The symptom is a burning sensation arising from the stomach or the lower chest.

        2) The symptom tends to appear frequently or is aggravated after eating, when bending a
        body forward, and/or when pressing on the abdomen.

        3. Patients categorized in "grade M" (discoloring type: minimal change) according to the
        Los Angeles System (2nd Modification) for Classification of Reflux Esophagitis.

        4. Patients who are 20 years old or older at the time of obtaining consent.

        5. Patients who are informed of the objective and details of this study and give written
        consent for study entry.

        <For the treatment period>

          1. Patients who have "heartburn" 2 days a week or more during 7 days until the treatment
             period (during the observation period).

          2. Patients with "heartburn diary" that is completely filled out during 7 days until the
             treatment period (during the observation period). If the observation period is 8 days
             or longer, those with a heartburn diary of which entries are fulfilled 80% or more
             during the observation period.

          3. Patients with 80% or better drug compliance for antacids during the observation
             period.

          4. Patients whose percentage of time showing pH<4.0 (% time pH<4.0) is not 0%* during the
             24-hour esophageal pH monitoring at the end of observation period (at the beginning of
             treatment period). *If parameters calculated from analytical program show 0.0% after
             round-off, this patient cannot be entered into the treatment period.

        Exclusion Criteria:

        Patients who meet any of the following criteria will be excluded from the study.

          1. Patients who cannot keep adequate entries of a heartburn diary by themselves.

          2. Patients who strongly complain "feeling of heavy stomach" and/or "abdominal bloating."

          3. Patients who have a complication or history of psychiatric or psychosomatic disease
             (e.g., manic-depressive psychosis, obsessive-compulsive neurosis, or others) or those
             who are on an antidepressant or anti-anxiety agent (accepted if only for a hypnotic
             treatment).

          4. Patients who have undergone Helicobacter pylori eradication therapy, and less than 6
             months* have elapsed from the end of H. pylori eradication therapy to the beginning of
             the observation period. *: The same day 6 months earlier, and the day at the end of 6
             months earlier if it is at the end of month.

          5. Patients with open gastric or duodenal ulcer.

          6. Patients with acute gastritis.

          7. Patients with a history of any surgical intervention that affect peptic secretion
             (e.g., upper gastrointestinal tract resection and/or vagotomy).

          8. Patients with Barrett's esophagus, esophageal stenosis, or pyloric stenosis.

          9. Patients with scleroderma.

         10. Patients with a history or complication of angina pectoris.

         11. Patients who work at night (working for a night-shift).

         12. Patients who received proton pump inhibitors (PPIs) within 3 weeks prior to
             pre-observation screening.

         13. Patients who need non steroidal anti-inflammatory drugs (NSAIDs) (except topical
             preparations), steroids (except topical preparations), and/or aspirin treatment every
             day.

         14. Patients receiving dialysis therapy.

         15. Patients with a serious complication such as cardiovascular disease (myocardial
             infarction, etc.), hematological disorder (e.g, aplastic anemia), renal disease (e.g.,
             acute or chronic renal failure), hepatic disease (e.g., cirrhosis), or malignant
             tumor.

         16. Patients with known hypersensitivity to antacids or PPIs.

         17. Patients who are pregnant or those with childbearing potential, or those who wish to
             become pregnant or are lactating during the study period.

         18. Patients receiving another investigational drug or those who received another
             investigational drug within 6 months prior to pre-observation screening* *:
             Registration is allowed on the same day of 6 months earlier, and the day at the end of
             6 months earlier if it is at the end of month.

         19. Patients who are judged to be ineligible for the study entry by the investigator or
             subinvestigator.
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? Entailment