Back to resultsThe Effects of Z-338 in Subjects With and Without Functional Dyspepsia
Primary Purpose
Dyspepsia
Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
Z-338
Sponsored by
About this trial
This is an interventional treatment trial for Dyspepsia
Eligibility Criteria
Inclusion Criteria: Subjects with functional dyspepsia Positive documented diagnosis of FD via RomeII criteria and three or more moderate symptoms of Gastrointestinal Score Subjects with no history of functional dyspepsia Clinical assessment, physical examination and laboratory testing without evidence for relevant abnormality. Other protocol-defined inclusion/exclusion criteria may apply.
Sites / Locations
- Royal Adelaide Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00298194
First Posted
February 28, 2006
Last Updated
January 12, 2009
Sponsor
Zeria Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT00298194
Brief Title
The Effects of Z-338 in Subjects With and Without Functional Dyspepsia
Official Title
The Effects of Z-338 on the Symptomatic Response to a Nutrient Challenge and Gastric Nutrient Distribution and Emptying in Subjects With and Without Functional Dyspepsia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Zeria Pharmaceutical
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To assess in subjects with and without functional dyspepsia the effects of Z-338 on:
Type and severity of symptoms a standardized nutrient challenge
The gastric nutrient distribution and gastric emptying of a standardized nutrient challenge
The association of the above with the manifestations of symptoms and symptom pattern
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspepsia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Z-338
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects with functional dyspepsia Positive documented diagnosis of FD via RomeII criteria and three or more moderate symptoms of Gastrointestinal Score
Subjects with no history of functional dyspepsia Clinical assessment, physical examination and laboratory testing without evidence for relevant abnormality.
Other protocol-defined inclusion/exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerald Holtmann, Professor
Organizational Affiliation
Royal Adelaide Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
The Effects of Z-338 in Subjects With and Without Functional Dyspepsia
We'll reach out to this number within 24 hrs