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

October 28, 2014 updated by: Astellas Pharma Inc
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

412

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Hokkaido, Japan
      • Kansai, Japan
      • Kantou, Japan
      • Kyushu, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 79 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Drug: YM443
oral
Other Names:
  • Z-338
  • acotiamide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Subject's global assessment
Time Frame: Every week
Every week

Secondary Outcome Measures

Outcome Measure
Time Frame
Disappearance rate of symptoms
Time Frame: Every week
Every week
Laboratory tests, resting
Time Frame: At 0, 4, 12, 24, 36, 48 week
At 0, 4, 12, 24, 36, 48 week
12-lead ECG
Time Frame: At 0, 24 and 48 week
At 0, 24 and 48 week
Adverse events
Time Frame: During treatment
During treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (ACTUAL)

December 1, 2009

Study Completion (ACTUAL)

December 1, 2009

Study Registration Dates

First Submitted

September 30, 2008

First Submitted That Met QC Criteria

October 1, 2008

First Posted (ESTIMATE)

October 2, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

October 29, 2014

Last Update Submitted That Met QC Criteria

October 28, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 443-CL-501

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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