- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00323817
To Evaluate the Efficacy and Safety in Subjects With Functional Dyspepsia
May 26, 2015 updated by: Zeria Pharmaceutical
To evaluate the efficacy and safety of Z-338 in subjects with Functional Dyspepsia
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
282
Phase
- Phase 2
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
-
-
-
Leuven, Belgium
- Leuven University
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-
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
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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:
-
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Global subject Outcome Assessment
Time Frame: 12 month
|
12 month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Individual symptom
Time Frame: 12 month
|
12 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jan Tack, PhD, MD, Leuven University
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
April 1, 2006
Primary Completion (Actual)
April 1, 2009
Study Completion (Actual)
October 1, 2009
Study Registration Dates
First Submitted
May 8, 2006
First Submitted That Met QC Criteria
May 8, 2006
First Posted (Estimate)
May 10, 2006
Study Record Updates
Last Update Posted (Estimate)
May 28, 2015
Last Update Submitted That Met QC Criteria
May 26, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 99010206E
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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