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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:
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
  Purpose

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 Intervention Phase
Peptic Ulcer
 Drug: AGN 201904
Drug: esomeprazole
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention

Resource links provided by NLM:

MedlinePlus related topics: Peptic Ulcer
U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Stomach or upper intestinal erosions

Enrollment: 150
Study Start Date: April 2006
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AGN 201904
Active Comparator: 2 Drug: esomeprazole

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00325715

Locations
United States, Texas
Houston, Texas, United States
Sponsors and Collaborators
Allergan
  More Information

No publications provided

Responsible Party: Therapeutic Area Head, Allergan, Inc
ClinicalTrials.gov Identifier: NCT00325715     History of Changes
Other Study ID Numbers: 201904-006
Study First Received: May 11, 2006
Last Updated: June 1, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Peptic Ulcer
Ulcer
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Pathologic Processes
 Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013