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

Allergan

Status and phase: Completed; Phase 1

Conditions: Peptic Ulcer

Treatments: Drug: esomeprazole; Drug: AGN 201904

Study type: Interventional

Funder types: Industry

Identifiers

NCT00325715

201904-006

Details and patient eligibility

About

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

Enrollment: 150 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: AGN 201904

2

Active Comparator group

Treatment:

Drug: esomeprazole