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

Peptic Ulcer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00325715
• Other study ID #: 201904-006
• Status: Completed
• Phase: Phase 1
• First received: May 11, 2006
• Last updated: June 1, 2011
• Start date: April 2006
• Est. completion date: August 2006

Study information

• Verified date: June 2011
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Peptic Ulcer

Intervention

Drug:
• AGN 201904

• esomeprazole

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stomach or upper intestinal erosions