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

Primary Purpose

Dyspepsia, Functional Dyspepsia

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
YM443
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyspepsia focused on measuring YM443, Z-338, Acotiamide, Rome III, Signs and symptoms, digestive

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Subject's global assessment

Secondary Outcome Measures

Disappearance rate of symptoms
Laboratory tests, resting
12-lead ECG
Adverse events

Full Information

First Posted
September 30, 2008
Last Updated
October 28, 2014
Sponsor
Astellas Pharma Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00764374
Brief Title
A Long-term, Open-label, Uncontrolled Trial of YM443 (Z-338) in Patients With Functional Dyspepsia
Official Title
A Long-term, Open-label, Uncontrolled Trial of YM443 (Z-338) in Patients With Functional Dyspepsia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspepsia, Functional Dyspepsia
Keywords
YM443, Z-338, Acotiamide, Rome III, Signs and symptoms, digestive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
412 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
YM443
Other Intervention Name(s)
Z-338, acotiamide
Intervention Description
oral
Primary Outcome Measure Information:
Title
Subject's global assessment
Time Frame
Every week
Secondary Outcome Measure Information:
Title
Disappearance rate of symptoms
Time Frame
Every week
Title
Laboratory tests, resting
Time Frame
At 0, 4, 12, 24, 36, 48 week
Title
12-lead ECG
Time Frame
At 0, 24 and 48 week
Title
Adverse events
Time Frame
During treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Central Contact
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Chair
Facility Information:
City
Hokkaido
Country
Japan
City
Kansai
Country
Japan
City
Kantou
Country
Japan
City
Kyushu
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
21934307
Citation
Matsueda K, Hongo M, Ushijima S, Akiho H. A long-term study of acotiamide in patients with functional dyspepsia: results from an open-label phase III trial in Japan on efficacy, safety and pattern of administration. Digestion. 2011;84(4):261-8. doi: 10.1159/000332404. Epub 2011 Sep 21.
Results Reference
background
Links:
URL
http://www.clinicaltrials.jp/user/ctrSearch.jsp
Description
Link to Results on JAPIC - enter 140642 in the JapicCTI-RNo. field (Japanese record)

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

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