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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00325715
First Posted: May 15, 2006
Last Update Posted: June 2, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Allergan
May 11, 2006
May 15, 2006
June 2, 2011
April 2006
August 2006   (Final data collection date for primary outcome measure)
Stomach or upper intestinal erosions
Stomach and upper intestinal erosions
Complete list of historical versions of study NCT00325715 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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AGN 201904 Versus Esomeprazole in the Prevention of Aspirin-induced Stomach or Upper Intestinal Damage in Healthy Volunteers
Not Provided
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
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
Peptic Ulcer
  • Drug: AGN 201904
  • Drug: esomeprazole
  • Experimental: 1
    Intervention: Drug: AGN 201904
  • Active Comparator: 2
    Intervention: Drug: esomeprazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
August 2006
August 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00325715
201904-006
Not Provided
Not Provided
Not Provided
Therapeutic Area Head, Allergan, Inc
Allergan
Not Provided
Not Provided
Allergan
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP