A Study of E3810 With Pre- and Post-Treatment pH Monitoring in Patients With Non-Erosive Gastroesophageal Reflux Disease

Inclusion Criteria

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

• 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.
• Patients who meet both 1) and 2) below;
• The symptom is a burning sensation arising from the stomach or the lower chest.
• The symptom tends to appear frequently or is aggravated after eating, when bending a body forward, and/or when pressing on the abdomen.
• Patients categorized in "grade M" (discoloring type: minimal change) according to the Los Angeles System (2nd Modification) for Classification of Reflux Esophagitis.
• Patients who are 20 years old or older at the time of obtaining consent.
• Patients who are informed of the objective and details of this study and give written consent for study entry.
• Patients who have "heartburn" 2 days a week or more during 7 days until the treatment period (during the observation period).
• 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.
• Patients with 80% or better drug compliance for antacids during the observation period.
• 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.

• Patients who cannot keep adequate entries of a heartburn diary by themselves.
• Patients who strongly complain "feeling of heavy stomach" and/or "abdominal bloating."
• 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).
• 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.
• Patients with open gastric or duodenal ulcer.
• Patients with acute gastritis.
• Patients with a history of any surgical intervention that affect peptic secretion (e.g., upper gastrointestinal tract resection and/or vagotomy).
• Patients with Barrett's esophagus, esophageal stenosis, or pyloric stenosis.
• Patients with scleroderma.
• Patients with a history or complication of angina pectoris.
• Patients who work at night (working for a night-shift).
• Patients who received proton pump inhibitors (PPIs) within 3 weeks prior to pre-observation screening.
• Patients who need non steroidal anti-inflammatory drugs (NSAIDs) (except topical preparations), steroids (except topical preparations), and/or aspirin treatment every day.
• Patients receiving dialysis therapy.
• 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.
• Patients with known hypersensitivity to antacids or PPIs.
• Patients who are pregnant or those with childbearing potential, or those who wish to become pregnant or are lactating during the study peri