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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 19, 2014