AGN 201904 Versus Esomeprazole in the Prevention of Aspirin-induced Stomach or Upper Intestinal Damage in Healthy Volunteers

Tracking Information
First Submitted Date ICMJE	May 11, 2006
First Posted Date ICMJE	May 15, 2006
Last Update Posted Date	June 2, 2011
Study Start Date ICMJE	April 2006
Actual Primary Completion Date	August 2006 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: May 15, 2006)	Stomach or upper intestinal erosions
Original Primary Outcome Measures ICMJE; (submitted: May 11, 2006)	Stomach and upper intestinal erosions
Change History	Complete list of historical versions of study NCT00325715 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	AGN 201904 Versus Esomeprazole in the Prevention of Aspirin-induced Stomach or Upper Intestinal Damage in Healthy Volunteers
Official Title ICMJE	Not Provided
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
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 1
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single; Primary Purpose: Prevention
Condition ICMJE	Peptic Ulcer
Intervention ICMJE	Drug: AGN 201904; Drug: esomeprazole
Study Arms	Experimental: 1 Intervention: Drug: AGN 201904; Active Comparator: 2 Intervention: Drug: esomeprazole
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: May 11, 2006)	150
Original Enrollment ICMJE	Same as current
Actual Study Completion Date	August 2006
Actual Primary Completion Date	August 2006 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 65 Years (Adult)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00325715
Other Study ID Numbers ICMJE	201904-006
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Therapeutic Area Head, Allergan, Inc
Study Sponsor ICMJE	Allergan
Collaborators ICMJE	Not Provided
Investigators ICMJE	Not Provided
PRS Account	Allergan
Verification Date	June 2011
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP