Clinical trial: A Comparative Study on the Efficacy and Safety of E3810 in Patients With Non-erosive Gastroesophageal Reflux Disease (NCT00165646)

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 for consecutive weeks during 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 the study and give written consent for
        study entry.

        <For the treatment period>

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

          2. Patients with "heartburn diary" that is completely filled out for 7 days until the
             treatment period (during the observation period). If the observation period is 8 days
             or longer, those with 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.

        Exclusion Criteria:

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

          1. Patients who cannot keep adequate entries of 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 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 (e.g., myocardial
             infarction), 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