Back to resultsTo Evaluate the Efficacy and Safety in Subjects With Functional Dyspepsia
Primary Purpose
Functional Dyspepsia
Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Z-338
Sponsored by
About this trial
This is an interventional treatment trial for Functional Dyspepsia
Eligibility Criteria
Inclusion Criteria: Subjects presenting diagnosis of FD as defined by the Rome II Subjects presenting postprandial fullness and/or Early satiety should be the most bothersome symptom Exclusion Criteria: -
Sites / Locations
- Leuven University
Outcomes
Primary Outcome Measures
Global subject Outcome Assessment
Secondary Outcome Measures
Individual symptom
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00323817
Brief Title
To Evaluate the Efficacy and Safety in Subjects With Functional Dyspepsia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Zeria Pharmaceutical
4. Oversight
5. Study Description
Brief Summary
To evaluate the efficacy and safety of Z-338 in subjects with Functional Dyspepsia
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
282 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Z-338
Primary Outcome Measure Information:
Title
Global subject Outcome Assessment
Time Frame
12 month
Secondary Outcome Measure Information:
Title
Individual symptom
Time Frame
12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects presenting diagnosis of FD as defined by the Rome II
Subjects presenting postprandial fullness and/or Early satiety should be the most bothersome symptom
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Tack, PhD, MD
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leuven University
City
Leuven
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
To Evaluate the Efficacy and Safety in Subjects With Functional Dyspepsia
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