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

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00764374
First received: September 30, 2008
Last updated: March 15, 2010
Last verified: March 2010
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Long-term, Open-label, Uncontrolled Trial of YM443 (Z-338) in Patients With Functional Dyspepsia

Resource links provided by NLM:

MedlinePlus related topics: Indigestion
U.S. FDA Resources

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 ]

Enrollment: 412
Study Start Date: August 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: YM443
oral
Other Names:
  • Z-338
  • acotiamide

  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

Locations
Japan
Hokkaido, Japan
Kansai, Japan
Kantou, Japan
Kyushu, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Central Contact Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Director, Astellas Pharma, Inc.
ClinicalTrials.gov Identifier: NCT00764374     History of Changes
Other Study ID Numbers: 443-CL-501
Study First Received: September 30, 2008
Last Updated: March 15, 2010
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:
YM443
Z-338
Acotiamide
Rome III
Signs and symptoms, digestive

Additional relevant MeSH terms:
Dyspepsia
Gastritis
Signs and Symptoms, Digestive
Signs and Symptoms
 Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on June 17, 2013