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COMPLETEDPHASE3

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

NCT00764374•Astellas Pharma Inc

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

Age

20 - 79 years

Sex

ALL

Healthy Volunteers

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
+6 more criteria

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

Locations (4)

Hokkaido, Japan

Kansai, Japan

Kantou, Japan

Kyushu, Japan

Key Dates

Start Date

August 1, 2008

Primary Completion Date

December 1, 2009

Completion Date

December 1, 2009

Last Updated

October 29, 2014

Enrollment

412

ACTUAL participants

Conditions

DyspepsiaFunctional Dyspepsia

Interventions

YM443

DRUG

Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia

NCT07182890

Functional DyspepsiaProbiotics+2 more

View study

RECRUITING

The Difference in Carbon Footprint Between Diagnostic Upper GI Endoscopy in Dyspeptic Patients Versus Therapeutic Upper GI Bleeding

NCT07261228

Carbon Footprint in Upper GI EndoscopyDyspepsia+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 29, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia

The Difference in Carbon Footprint Between Diagnostic Upper GI Endoscopy in Dyspeptic Patients Versus Therapeutic Upper GI Bleeding

Saccharomyces Boulardii Combined With Bismuth Quadruple Therapy for Helicobacter Pylori Rescue Treatment

Bio-electrical Impedance Analysis in Patients With Functional Dyspepsia

High Resolution Gastric Mapping and Gastroduodenal Manometry

The Brain-Heart-Gut Connection