A Long-term, Open-label, Uncontrolled Trial of YM443 (Z-338) in Patients With Functional Dyspepsia

Inclusion criteria

• Patient showing at least one of the following 4 symptoms from more than 6 months before obtaining consent

• postprandial fullness
• early satiation
• upper abdominal pain
• upper abdominal discomfort
• Patient showing at least 2 of the 8 symptoms shown below repeatedly from 3 months before obtaining consent (At least one symptom of either postprandial fullness or early satiation should be included.)
• Patient showing either postprandial fullness, bloating in the upper abdomen, or early satiation as the major complaint among the 8 symptoms shown below at the time of obtaining consent

• upper abdominal pain
• upper abdominal discomfort
• postprandial fullness
• bloating in the upper abdomen
• early satiation
• nausea
• vomiting
• belching
• Outpatient

Exclusion criteria

• Patient showing symptoms of organic disease (reflux esophagitis, erosion, ulceration, esophageal hiatal hernia, bleeding, malignant tumor, Barrett's esophagus) when upper gastrointestinal endoscopy is performed within 24 weeks before obtaining consent
• Patient showing heartburn within 12 weeks before obtaining consent
• Patient complicated by irritable bowel syndrome
• Patient complicated by diabetes mellitus requiring medication
• Patient complicated by severe anxiety disorder with some problems in interpersonal relationships or social life
• Patient complicated by depression (including suspected cases) or sleep disturbance