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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00764374
Recruitment Status : Completed
First Posted : October 2, 2008
Last Update Posted : October 29, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Dyspepsia Functional Dyspepsia Drug: YM443 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 412 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Long-term, Open-label, Uncontrolled Trial of YM443 (Z-338) in Patients With Functional Dyspepsia
Study Start Date : August 2008
Primary Completion Date : December 2009
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Drug: YM443
oral
Other Names:
  • Z-338
  • acotiamide


Outcome Measures

Primary Outcome Measures :
  1. Subject's global assessment [ Time Frame: Every week ]

Secondary Outcome Measures :
  1. Disappearance rate of symptoms [ Time Frame: Every week ]
  2. Laboratory tests, resting [ Time Frame: At 0, 4, 12, 24, 36, 48 week ]
  3. 12-lead ECG [ Time Frame: At 0, 24 and 48 week ]
  4. Adverse events [ Time Frame: During treatment ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00764374     History of Changes
Other Study ID Numbers: 443-CL-501
First Posted: October 2, 2008    Key Record Dates
Last Update Posted: October 29, 2014
Last Verified: October 2014

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