Rabeprazole Protection of Aspirin Induced Gastric Damage.

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

Summary

To determine the effectiveness of rabeprazole in preventing or decreasing acute gastroduodenal injury caused by therapeutic doses of aspirin in a placebo-controlled, randomized, double-blind parallel group study.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Temple University
• Treatments: Aspirin; Rabeprazole

Criteria

Thirty (30) normal subjects will be recruited.

Inclusion criteria:

• A normal subject must be between 18 and 60 years of age with no history of gastrointestinal disease, gastroduodenal surgery, upper gastrointestinal symptoms or cardiopulmonary disease of any kind.

Exclusion Criteria:

• Normal subjects should have not ingested a salicylate, nonsteroidal antiinflammatory drug, histamine-2 receptor antagonist, proton pump inhibitor, misoprostol or carafate within one month of entering this study.

• He/she should not have participated in an investigational study within 3 months of this protocol.

• Pregnant women and women not using an accepted method of birth control will be excluded.

• Patients will be excluded who are allergic to aspirin and NSAIDs, who have an intolerance to aspirin and NSAIDs, who have a history of asthma and/or nasal polyps.

• Patients will be excluded if they have a history of gastric ulcers, duodenal ulcers, gastrointestinal bleeding, or bleeding disorder, clotting disorder.

• Patients will be excluded who actively abuse alcohol, as defined by greater than three twelve ounce beers or greater than three drinks containing hard liquor per day.

• Patients with a history of intracranial bleeding and/or brain trauma will be excluded from this research.