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

Phase 1

Completed

• Conditions: Peptic Ulcer
• Interventions: Drug: AGN 201904; Drug: esomeprazole

• Registration Number: NCT00325715
• Lead Sponsor: Allergan

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-05-11
• Study First Submitted QC: 2006-05-11
• Study First Posted: 2006-05-15
• Primary Completion: 2006-08
• Study Completion: 2006-08
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-01
• Last Update Posted: 2011-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AGN 201904	-
2	esomeprazole	-

Primary Outcome Measures

Name	Time	Method
Stomach or upper intestinal erosions