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

This study has been completed.

Sponsor:

Information provided by:

Allergan

ClinicalTrials.gov Identifier:

NCT00325715

First received: May 11, 2006

Last updated: June 1, 2011

Last verified: June 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	May 11, 2006
Last Updated Date	June 1, 2011
Start Date ^ICMJE	April 2006
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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Prevention
Condition ^ICMJE	Peptic Ulcer
Intervention ^ICMJE	Drug: AGN 201904 Drug: esomeprazole
Study Arm (s)	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
Enrollment ^ICMJE	150
Completion Date	August 2006
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
Gender	Both
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
Plan to Share Data	Not Provided
IPD Description	Not Provided
Responsible Party	Therapeutic Area Head, Allergan, Inc
Study Sponsor ^ICMJE	Allergan
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Allergan
Verification Date	June 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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