Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-28 @ 12:14 AM
Study NCT ID:
NCT01061034
Status:
COMPLETED
Last Update Posted:
2010-02-02
First Post:
2009-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pharmacological Study That Measures Omeprazole Effect on Aspirins Absorption in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}, {'id': 'D009853', 'term': 'Omeprazole'}], 'ancestors': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kerendoenyas@gmail.com', 'phone': '972-57-7346651', 'title': 'Dr. Keren Doenyas-Barak', 'organization': 'Assaf Harofeh medical center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Aspirin Then Aspirin Plus Omeprazole', 'description': '7 days of Aspirin (100mg) alone, followed by 14 days of Aspirin and Omeprazole (20mg BID for 3 days and then 20mg once daily', 'otherNumAtRisk': 9, 'otherNumAffected': 1, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'mild dyspepsia', 'notes': 'one volunteer complained mild dyspepsia unther aspirin treatment alone. his complaine resolved withoud any special intervention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Aspirin Level in Blood (Area Under the Curve)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aspirin Then Aspirin Plus Omeprazole', 'description': '7 days of Aspirin (100mg) alone, followed by 14 days of Aspirin and Omeprazole (20mg BID for 3 days and then 20mg once daily'}], 'classes': [{'title': 'aspirin area under the curve on day 7', 'categories': [{'measurements': [{'value': '49.4', 'spread': '13.5', 'groupId': 'OG000'}]}]}, {'title': 'aspirin area under the curve on day 21', 'categories': [{'measurements': [{'value': '50.7', 'spread': '15.3', 'groupId': 'OG000'}]}]}, {'title': '1 hour after admission day 7 (aspirin alone)', 'categories': [{'measurements': [{'value': '8.7', 'spread': '4', 'groupId': 'OG000'}]}]}, {'title': '1 hour after admission day 21 (aspirin+omeprazole)', 'categories': [{'measurements': [{'value': '6.5', 'spread': '4.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'on day 7,on day 21', 'description': 'Aspirins pharmacokinetics: aspirin blood level determined by use of high performance liquid chromatography (HPLC) at baseline, 1, 2,4,6,10 and 24 hours after administration of aspirin on day 7 and on day 21.\n\nThe area unther the time vs. concentration curve of the reccurent measurments(AUC) reflects bioavailability of aspirin.', 'unitOfMeasure': 'mg*hour/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '9 volunteers completed the study, one volunteer was excluded from pharmacokinetics, because serum salicylic acid concentration was not at the baseline (non-detectable) in the 0-hour sample.', 'anticipatedPostingDate': '2007-04'}, {'type': 'SECONDARY', 'title': 'Platelet Function Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aspirin Then Aspirin Plus Omeprazole', 'description': '7 days of Aspirin (100mg) alone, followed by 14 days of Aspirin and Omeprazole (20mg BID for 3 days and then 20mg once daily'}], 'classes': [{'title': 'day 0', 'categories': [{'measurements': [{'value': '80', 'spread': '4.18', 'groupId': 'OG000'}]}]}, {'title': 'day 7', 'categories': [{'measurements': [{'value': '8.55', 'spread': '2.45', 'groupId': 'OG000'}]}]}, {'title': 'day 21', 'categories': [{'measurements': [{'value': '8.77', 'spread': '2.38', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'on day 0 as a baseline and on day 7 and 21 of the study.', 'description': 'Platelet function tests were determined by optical whole blood aggregometry in response to arachidonic acid and adenosine diphosphate.\n\nthe results reflects the percent of active platelets.', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2007-01'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aspirin Then Aspirin Plus Omeprazole', 'description': '7 days of Aspirin (100mg) alone, followed by 14 days of Aspirin and Omeprazole (20mg BID for 3 days and then 20mg once daily'}], 'periods': [{'title': 'Aspirin', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Aspirin Plus Omeprazole', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'healthy volunteers were recruted on march 2007. all of the patients are co-workers in the department of medicine in assaf harofeh medical center.', 'preAssignmentDetails': 'one volunteer was excluded before enrollment due to recent consumption of NSAIDS'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Aspirin Then Aspirin Plus Omeprazole', 'description': '7 days of Aspirin (100mg) alone, followed by 14 days of Aspirin and Omeprazole (20mg BID for 3 days and then 20mg once daily'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.3', 'spread': '12.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-01-02', 'studyFirstSubmitDate': '2009-05-03', 'resultsFirstSubmitDate': '2009-05-03', 'studyFirstSubmitQcDate': '2010-01-02', 'lastUpdatePostDateStruct': {'date': '2010-02-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-01-02', 'studyFirstPostDateStruct': {'date': '2010-02-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aspirin Level in Blood (Area Under the Curve)', 'timeFrame': 'on day 7,on day 21', 'description': 'Aspirins pharmacokinetics: aspirin blood level determined by use of high performance liquid chromatography (HPLC) at baseline, 1, 2,4,6,10 and 24 hours after administration of aspirin on day 7 and on day 21.\n\nThe area unther the time vs. concentration curve of the reccurent measurments(AUC) reflects bioavailability of aspirin.'}], 'secondaryOutcomes': [{'measure': 'Platelet Function Tests', 'timeFrame': 'on day 0 as a baseline and on day 7 and 21 of the study.', 'description': 'Platelet function tests were determined by optical whole blood aggregometry in response to arachidonic acid and adenosine diphosphate.\n\nthe results reflects the percent of active platelets.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pharmacokinetics', 'aspirin', 'proton pump inhiditor'], 'conditions': ['Aspirin Blood Level', 'Proton Pump Inhiditor Treatment']}, 'descriptionModule': {'briefSummary': "Aspirin is a weak acid that crosses the gastric and intestinal mucosa by passive diffusion while in its lipophilic nature.Omeprazole, a proton pump inhibitor, inhibits gastric acid secretion.\n\nWe assumed that omeprazole inhibits aspirin absorption, thus reducing its action on platelets.\n\nhealthy volunteers, with no known peptic disease or bleeding disorders will be enrolled.\n\nAll volunteers will receive 7 days of Aspirin (100mg) alone, followed by 14 days of Aspirin and Omeprazole 20mg twice daily for 3 days and then 20mg once daily.\n\nBlood levels of Aspirin will be determined by High performance liquid chromatography (HPLC), 0, 1, 2, 4, 6, 10, 24 hours after the administration of Aspirin alone on day 7 and Aspirin plus Omeprazole on day 21.\n\nPlatelet function tests will be determined by platelet-rich plasma aggregometry in response to Arachidonic acid (500mg/ml), Ristocetin (1.5mg/ml) and Adenosine 5'-diphosphate (20mM) on day 0 as baseline and on day 7 and 21 of the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-healthy volunteers\n\nExclusion Criteria:\n\n* pretreatment with aspirin\n* pretreatment with non steroidal anti inflamatory drugs\n* pretreatment with antacids\n* history of peptic ulcer disease\n* coagulation or aggregation disorder.'}, 'identificationModule': {'nctId': 'NCT01061034', 'briefTitle': 'Pharmacological Study That Measures Omeprazole Effect on Aspirins Absorption in Healthy Volunteers', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Assaf-Harofeh Medical Center'}, 'officialTitle': 'The Effect of Proton Pump Inhibitor (Omeprazole) on Acetosalisylic Acid Absorption.', 'orgStudyIdInfo': {'id': '180/07'}}, 'armsInterventionsModule': {'interventions': [{'name': 'aspirin and omeprazole', 'type': 'DRUG', 'description': 'aspirin 100 mg, once daily aspirin 100 mg and omeprazole 20 mg both once daily.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ẕerifin', 'country': 'Israel', 'facility': 'Assaf Harofeh Medical Center', 'geoPoint': {'lat': 31.95731, 'lon': 34.84852}}], 'overallOfficials': [{'name': 'ahuva golik, prop.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'asaf-harofemedical center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assaf-Harofeh Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'dr. keren doenyas barak', 'oldOrganization': 'internal medicine A asaf-harofeh medical center'}}}}