Rabeprazole Protection of Aspirin Induced Gastric Damage.
Information source: Temple University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Normal Subjects
Intervention: Rabeprazole (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Temple University Official(s) and/or principal investigator(s):
Robert S Fisher, MD, Principal Investigator, Affiliation: Temple University
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.
Clinical Details
Official title: Rapid Protection of the Gastroduodenal Mucosa Against Aspirin-Induced Damage by Rabeprazole
Study design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Gastric mucosal abnormalities
Secondary outcome: Hemoglobin
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 to Temple from Janssen Pharmaceuticals. The randomization schedule
will be prepared by John Gaughan, PhD of Temple University School of Medicine Department of
Biostatistics using a random number generator. The coded medications will be dispensed by
Temple's Department of Pharmacy. Study subjects and the investigators will be blinded as to
the subject receiving either placebo or rabeprazole. The sealed code will not be broken
until after the data analysis.
Study subjects will be admitted to the Temple Clinical Research Center for the duration of
the study. Appendix I has the study time line. Study subjects will arrive at the CRC at
6: 00 A. M. on study day 1. Female subjects will have a urine pregnancy test performed. Blood
tests will be obtained for salicylate and alcohol levels. Each study subject will receive a
single dose of study drug (rabeprazole or placebo) at 7: 00 A. M. on study days 1, 2 and 3—one
hour before breakfast on days 1 and 3 and 90 minutes before breakfast on study day 2. All
research subjects will receive aspirin (ASA), 325 mg tablets as 2 tablets with 8 oz. water
every 4 hours at 8: 30 A. M., 12: 30 P. M., 4: 30 P. M., 8: 30 P. M., 12: 30 A. M. and 4: 30 A. M. daily
for study days 1, 2 and 3 (a total of 3900 mg aspirin per day). Esophagogastroduodenoscopy
will be performed at 8: 00 A. M. on the mornings of days 2 and 4; that is, 24 hours and 72
hours after initiation of aspirin and test drug. During each endoscopy, the maximum number
of submucosal hemorrhages and erosions in an endoscopic field from the anterior and posterior
walls of the antrum will be counted. In addition, a Lanza score will be assigned for each
endoscopic examination (Appendix II). Endoscopic photographs will be obtained for each
endoscopic examination. A blood sample will be obtained at 7: 00 A. M. on study days 2, 3 and
4 for measurement of hemoglobin and serum salicylate. Meals will be standardized as follows
for each day of the study:
Breakfast: 8: 00 A. M. (study days 1 and 3); 8: 30 A. M. (study day 2) 2 eggs, 2 slices of soft
white bread, 4 oz unsweetened orange juice Lunch: 1: 00 P. M. (study days 1, 2 and 3) Turkey
sandwich, 2 slices of wheat bread, lettuce, tomato, 1 orange, 8 oz apple juice Dinner: 6: 00
P. M. (study days 1, 2 and 3) Two plain hamburgers, ketchup, mustard, lettuce and tomato;
tossed green salad with thousand island dressing, 1 cup of French fries, 8 oz whole milk
Snack: 10: 00 P. M. (study days 1, 2 and 3) 4 graham crackers, 4 oz orange juice
If the Lanza score reaches 4 for any subject indicating widespread involvement of the stomach
with submucosal hemorrhages, erosions, or ulcerations, that subject will not receive any more
aspirin, but continue with study drug of placebo or rabeprazole. If this was detected on day
2 of the study, the subject will continue to receive the study drug with the repeat study
endoscopy on day 4. If the Lanza score day 4 (the end of the study) is 4, the subject will
be treated with rabeprazole 20 mg po qd for one month. If there was an ulcer, a repeat upper
endoscopy will then be performed at 4 weeks to ensure healing.
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
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.
Locations and Contacts
Temple University School of Medicine, Philadelphia, Pennsylvania 19140, United States
Additional Information
Starting date: September 2005
Ending date: September 2007
Last updated: January 2, 2008
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