Back to resultsThe Effect of Z-338 in Subjects With Functional Dyspepsia
Primary Purpose
Functioanl Dyspepsia
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Z-338
Sponsored by
About this trial
This is an interventional treatment trial for Functioanl Dyspepsia
Eligibility Criteria
Inclusion Criteria:
- Postprandial fullness, upper abdominal bloating and/or early satiety should be at least moderate for 2 days or more at the 7 days at Visit 1.
- Upper abdominal pain, upper abdominal discomfort, postprandial fullness, upper abdominal bloating, early satiety, nausea, vomit and belching should be at least moderate for at least 2 symptoms for 2 days or more at the 7 days at Visit 1.
Exclusion Criteria:
- Subjects that heartburn should be the most bothersome symptom
- Subjects presenting with primary complaints relieved by stool movements (IBS)
- Subjects with diabetes by treatment
- Subjects that heartburn should be more than moderate
Sites / Locations
- Kawasaki Medical School
Outcomes
Primary Outcome Measures
Distal stomach square, Gastric emptying, Motility index, Duodenogastric reflux index
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00458328
Brief Title
The Effect of Z-338 in Subjects With Functional Dyspepsia
Official Title
The Effect of Z-338 in Subjects With Functional Dyspepsia, Evaluate the Function of Gastro-duodenum by Ultrasound
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Zeria Pharmaceutical
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Z-338; PhaseIIb, Single-centre, Randomized, Double-blind, Placebo-controlled, Parallel group study in Subjects with Functional Dyspepsia, evaluate the motility of gastro-duodenum by ultrasound
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functioanl Dyspepsia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Z-338
Primary Outcome Measure Information:
Title
Distal stomach square, Gastric emptying, Motility index, Duodenogastric reflux index
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:
Postprandial fullness, upper abdominal bloating and/or early satiety should be at least moderate for 2 days or more at the 7 days at Visit 1.
Upper abdominal pain, upper abdominal discomfort, postprandial fullness, upper abdominal bloating, early satiety, nausea, vomit and belching should be at least moderate for at least 2 symptoms for 2 days or more at the 7 days at Visit 1.
Exclusion Criteria:
Subjects that heartburn should be the most bothersome symptom
Subjects presenting with primary complaints relieved by stool movements (IBS)
Subjects with diabetes by treatment
Subjects that heartburn should be more than moderate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ken Haruma, MD, PhD
Organizational Affiliation
Kawasaki Medical School
Official's Role
Study Chair
Facility Information:
Facility Name
Kawasaki Medical School
City
Kurashiki
State/Province
Okayama
ZIP/Postal Code
701-0192
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
The Effect of Z-338 in Subjects With Functional Dyspepsia
We'll reach out to this number within 24 hrs