A Long-Term, Open-Label, Uncontrolled Trial of YM443 (Z-338) in Patients With Functional Dyspepsia - Full Text View

Sponsored by:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00764374

Purpose

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.

Condition	Intervention	Phase
Dyspepsia Functional Dyspepsia	Drug: YM443	Phase III

MedlinePlus related topics: Indigestion

Drug Information available for: Acotiamide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Long-Term, Open-Label, Uncontrolled Trial of YM443 (Z-338) in Patients With Functional Dyspepsia

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Subject's global assessment [ Time Frame: Every week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Disappearance rate of symptoms [ Time Frame: Every week ] [ Designated as safety issue: No ]
Laboratory tests, resting [ Time Frame: At 0, 4, 12, 24, 36, 48 week ] [ Designated as safety issue: Yes ]
12-lead ECG [ Time Frame: At 0, 24 and 48 week ] [ Designated as safety issue: Yes ]
Adverse events [ Time Frame: During treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	330
Study Start Date:	August 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: YM443 oral

Eligibility

Ages Eligible for Study:	20 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00764374

Contacts

Contact: Clinical Development Administration Dept

clinicaltrials_info@jp.astellas.com

Locations

Japan
	Recruiting
Hokkaido, Japan
	Recruiting
Kantou, Japan
	Recruiting
Kansai, Japan
	Recruiting
Kyushu, Japan

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Chair:

Central Contact

Astellas Pharma Inc

More Information

Responsible Party:	Astellas Pharma, Inc. ( Director )
Study ID Numbers:	443-CL-501
Study First Received:	September 30, 2008
Last Updated:	October 1, 2008
ClinicalTrials.gov Identifier:	NCT00764374
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:

YM443
Z-338
Acotiamide
Rome III
Signs and symptoms, digestive

Study placed in the following topic categories:

Signs and Symptoms
Stomach Diseases
Digestive System Diseases
Signs and Symptoms, Digestive

Gastrointestinal Diseases
Gastroenteritis
Dyspepsia
Gastritis

ClinicalTrials.gov processed this record on January 13, 2009