Back to resultsTo Evaluate the Efficacy of Z-338 in Subjects With Functional Dyspepsia
Primary Purpose
Functional 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 Functional 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 taht heartburn should be the most bothersome symptom Subjects presenting with primary complaints relieved by stool movements (IBS) Subjects with diabetes by treatment Subjects taht heartburn should be more than moderate
Sites / Locations
- Tohoku University
Outcomes
Primary Outcome Measures
General impression at last visit
Secondary Outcome Measures
General impression at each week
Individual symptom score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00333372
Brief Title
To Evaluate the Efficacy of Z-338 in Subjects With Functional Dyspepsia
Official Title
To Evaluate the Efficacy of Z-338 in Subjects With Functional Dyspepsia, Focusing on the Assessment of Subjective Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Zeria Pharmaceutical
4. Oversight
5. Study Description
Brief Summary
To Evaluate the efficacy of Z-338 in subjects with Functional Dyspepsia, focusing on the assessment of subjective symptoms in order to further determine the optimal dosage and efficacy parameters for PhaseIII clinical trials.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Dyspepsia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
440 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Z-338
Primary Outcome Measure Information:
Title
General impression at last visit
Secondary Outcome Measure Information:
Title
General impression at each week
Title
Individual symptom score
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 taht heartburn should be the most bothersome symptom
Subjects presenting with primary complaints relieved by stool movements (IBS)
Subjects with diabetes by treatment
Subjects taht heartburn should be more than moderate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michio Hongo, Professor
Organizational Affiliation
Tohoku University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Tohoku University
City
Sendai
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
To Evaluate the Efficacy of Z-338 in Subjects With Functional Dyspepsia
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