Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00220857
Status:
COMPLETED
Last Update Posted:
2008-01-11
First Post:
2005-09-20
Brief Title:
Rabeprazole Protection of Aspirin Induced Gastric Damage
Sponsor:
Temple University
Organization:
Temple University
Study Overview
Official Title:
Rapid Protection of the Gastroduodenal Mucosa Against Aspirin-Induced Damage by Rabeprazole
Status:
COMPLETED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 group study
Detailed Description:
Thirty 30 eligible normal subjects will be randomized to one of two study groups rabeprazole 20 mg OD n15 or placebo OD n15 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 Temples 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 600 AM 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 700 AM 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 830 AM 1230 PM 430 PM 830 PM 1230 AM and 430 AM daily for study days 1 2 and 3 a total of 3900 mg aspirin per day Esophagogastroduodenoscopy will be performed at 800 AM 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 700 AM 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 800 AM study days 1 and 3 830 AM study day 2 2 eggs 2 slices of soft white bread 4 oz unsweetened orange juice Lunch 100 PM study days 1 2 and 3 Turkey sandwich 2 slices of wheat bread lettuce tomato 1 orange 8 oz apple juice Dinner 600 PM 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 1000 PM 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
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 600 AM 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 700 AM 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 830 AM 1230 PM 430 PM 830 PM 1230 AM and 430 AM daily for study days 1 2 and 3 a total of 3900 mg aspirin per day Esophagogastroduodenoscopy will be performed at 800 AM 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 700 AM 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 800 AM study days 1 and 3 830 AM study day 2 2 eggs 2 slices of soft white bread 4 oz unsweetened orange juice Lunch 100 PM study days 1 2 and 3 Turkey sandwich 2 slices of wheat bread lettuce tomato 1 orange 8 oz apple juice Dinner 600 PM 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 1000 PM 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None