Status:
COMPLETED
A Long-term, Open-label, Uncontrolled Trial of YM443 (Z-338) in Patients With Functional Dyspepsia
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Dyspepsia
Functional Dyspepsia
Eligibility:
All Genders
20-79 years
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
412 Patients enrolled
Trial Details
Trial ID
NCT00764374
Start Date
August 1 2008
End Date
December 1 2009
Last Update
October 29 2014
Active Locations (4)
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1
Hokkaido, Japan
2
Kansai, Japan
3
Kantou, Japan
4
Kyushu, Japan