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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014