Back to resultsAGN 201904 Versus Esomeprazole in the Prevention of Aspirin-induced Stomach or Upper Intestinal Damage in Healthy Volunteers
Primary Purpose
Peptic Ulcer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AGN 201904
esomeprazole
Sponsored by
About this trial
This is an interventional prevention trial for Peptic Ulcer
Eligibility Criteria
Inclusion Criteria: Healthy Adult Volunteers who have provided written informed consent Exclusion Criteria: Volunteers with a history of upper gastrointestinal disease or who have a current diagnosis of upper gastrointestinal disease. Female volunteers who pregnant, nursing, or planning a pregnancy Volunteers with a history of drug or alcohol abuse
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Stomach or upper intestinal erosions
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00325715
Brief Title
AGN 201904 Versus Esomeprazole in the Prevention of Aspirin-induced Stomach or Upper Intestinal Damage in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Allergan
4. Oversight
5. Study Description
Brief Summary
AGN 201904, a proton pump inhibitor, versus esomeprazole in the prevention of stomach or upper intestinal damage following administration of high-dose aspirin in healthy volunteers
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peptic Ulcer
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
AGN 201904
Intervention Type
Drug
Intervention Name(s)
esomeprazole
Primary Outcome Measure Information:
Title
Stomach or upper intestinal erosions
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy Adult Volunteers who have provided written informed consent
Exclusion Criteria:
Volunteers with a history of upper gastrointestinal disease or who have a current diagnosis of upper gastrointestinal disease.
Female volunteers who pregnant, nursing, or planning a pregnancy
Volunteers with a history of drug or alcohol abuse
Facility Information:
City
Houston
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Learn more about this trial
AGN 201904 Versus Esomeprazole in the Prevention of Aspirin-induced Stomach or Upper Intestinal Damage in Healthy Volunteers
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