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

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. Identifier: NCT00325715
Recruitment Status : Completed
First Posted : May 15, 2006
Last Update Posted : June 2, 2011
Information provided by:

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

Condition or disease Intervention/treatment Phase
Peptic Ulcer Drug: AGN 201904 Drug: esomeprazole Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
Study Start Date : April 2006
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Peptic Ulcer

Arm Intervention/treatment
Experimental: 1 Drug: AGN 201904
Active Comparator: 2 Drug: esomeprazole

Primary Outcome Measures :
  1. Stomach or upper intestinal erosions

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00325715

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United States, Texas
Houston, Texas, United States
Sponsors and Collaborators
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Responsible Party: Therapeutic Area Head, Allergan, Inc Identifier: NCT00325715    
Other Study ID Numbers: 201904-006
First Posted: May 15, 2006    Key Record Dates
Last Update Posted: June 2, 2011
Last Verified: June 2011
Additional relevant MeSH terms:
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Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action