Status:
COMPLETED
Rabeprazole Protection of Aspirin Induced Gastric Damage.
Lead Sponsor:
Temple University
Conditions:
Normal Subjects
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief 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 ...
Detailed Description
Thirty (30) eligible normal subjects will be randomized to one of two study groups: rabeprazole 20 mg OD (n=15) or placebo OD (n=15). Both rabeprazole and identically appearing placebo will be given t...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00220857
Start Date
September 1 2005
End Date
September 1 2007
Last Update
January 11 2008
Active Locations (1)
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1
Temple University School of Medicine
Philadelphia, Pennsylvania, United States, 19140