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

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To examine the safety and efficacy of Z-338 (YM443) after long-term administration in patients with functional dyspepsia, and also to examine the pattern of long-term administration.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Z 338

Criteria

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