Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT00137033
Status:
COMPLETED
Last Update Posted:
2021-03-03
First Post:
2005-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Celebrex Low Dose ASA Study Examining the Incidence of Gastroduodenal Ulcers in a Healthy Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010437', 'term': 'Peptic Ulcer'}], 'ancestors': [{'id': 'D004378', 'term': 'Duodenal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068579', 'term': 'Celecoxib'}, {'id': 'D009288', 'term': 'Naproxen'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009280', 'term': 'Naphthaleneacetic Acids'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 605}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2005-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-01', 'studyFirstSubmitDate': '2005-08-26', 'studyFirstSubmitQcDate': '2005-08-26', 'lastUpdatePostDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-08-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare the incidence of gastroduodenal endoscopic ulcers between celecoxib 200 mg QD plus ASA 81 mg QD vs. naproxen 500 mg BID plus ASA 81 mg QD in healthy subjects (50-75 years old).'}], 'secondaryOutcomes': [{'measure': 'Compare the incidence of gastroduodenal endoscopic ulcers between celecoxib plus ASA vs placebo plus ASA in healthy subjects (50-75 years of age) Compare the incidence of gastroduodenal endoscopic ulcers between naproxen plus ASA vs. placebo plus ASA'}]}, 'conditionsModule': {'conditions': ['Peptic Ulcers']}, 'descriptionModule': {'briefSummary': 'The aim of the current study is to replicate the COXA-0508-258 study in a multicenter, US setting, using a lower dose of ASA. It is expected that this study will not only confirm the results of the 258 study but show that the incidence of UGI ulcers on celecoxib is significantly less than on traditional NSAIDs and the incidence of UGI ulcers on celecoxib increases with the addition of ASA, but still is lower than traditional NSAIDs plus/minus ASA. This 7-day study is designed to compare the incidence of gastroduodenal ulcers associated with celecoxib 200 mg QD and low dose aspirin 81 mg QD and with naproxen 500 mg BID plus low dose aspirin 81 mg QD in healthy adults(50-75 years of age).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* A healthy adult between 50 and 75 years of age inclusive: of normal clinical laboratory test results during the Screening Visit or, if abnormal, are not clinically significant in the Investigator's opinion.\n\nExclusion Criteria:\n\n* A gastric, pyloric channel or duodenal ulcer (defined as any break in the mucosa at least 3 mm in diameter with unequivocal depth) or more than 5 erosions in the stomach or duodenum ( the UGI endoscopic score greater or less) on the baseline UGI endoscopy"}, 'identificationModule': {'nctId': 'NCT00137033', 'briefTitle': 'Celebrex Low Dose ASA Study Examining the Incidence of Gastroduodenal Ulcers in a Healthy Population', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Multicenter, Randomized, Active-Controlled Comparison Study of the Incidence of Gastroduodenal Ulcers Associated With Celecoxib and Low Dose ASA Versus Naproxen and Low Dose ASA in Healthy Subjects (50-75 Years of Age)', 'orgStudyIdInfo': {'id': 'A3191171'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Celecoxib', 'type': 'DRUG'}, {'name': 'Naproxen', 'type': 'DRUG'}, {'name': 'ASA', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '06030-0001', 'city': 'Farmington', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.71982, 'lon': -72.83204}}, {'zip': '06708', 'city': 'Waterbury', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.55815, 'lon': -73.0515}}, {'zip': '33458', 'city': 'Jupiter', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 26.93422, 'lon': -80.09421}}, {'zip': '33173', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '34761', 'city': 'Ocoee', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 28.56917, 'lon': -81.54396}}, {'zip': '33024', 'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United 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{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27612', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '28401', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '16635', 'city': 'Duncansville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 40.42341, 'lon': -78.4339}}, {'zip': '37404', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United 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"Pfizer's Upjohn has merged with Mylan to form Viatris Inc.", 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}