Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-30 @ 11:14 AM
Study NCT ID:
NCT01796951
Status:
COMPLETED
Last Update Posted:
2017-04-04
First Post:
2013-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Dose Aspirin Inhibition of COX-2 Derived PGE2 in Male Smokers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014029', 'term': 'Tobacco Use Disorder'}, {'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}, {'id': 'D000068579', 'term': 'Celecoxib'}, {'id': 'C494814', 'term': 'BID protein, human'}], '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': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-30', 'studyFirstSubmitDate': '2013-02-14', 'studyFirstSubmitQcDate': '2013-02-19', 'lastUpdatePostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-02-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in COX-2 dependent urinary PGE-M (ng/mg Cr) production after 16 days of aspirin treatment', 'timeFrame': '16 days', 'description': 'Baseline urinary PGE-2 metabolite (PGE-M) will be measured. Then after 3 days of COX-2 blockade with celecoxib, it will again be measured. Participants will then undergo 10 days of treatment with aspirin and urinary PGE-M will be measured. Finally, participants will be treated with combined aspirin and celecoxib for 3 days and urinary PGE-M will be measured one last time. Using these values, the degree of aspirin inhibition of COX-2 specific urinary PGE-M production can be calculated.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tobacco Use Disorder', 'Smoking']}, 'descriptionModule': {'briefSummary': "Regular aspirin use has been associated with a reduction in the development of a number of different malignancies including lung cancer. The mechanism of aspirin's cancer prevention is not known. This study will evaluate whether once daily aspirin use can reduce the production of a protein named prostaglandin E2 (PGE-2), which is known to promote cancer. Specifically, this study will evaluate if aspirin can inhibit the production of PGE-2 by blocking an enzyme named cycloxygenase-2 (COX-2). To accomplish these goals, participants will take either aspirin 325 mg daily, celecoxib 200 mg twice daily, or the combination of both during various days of this 16-day study. Urine be collected to evaluate for PGE-2 production at 4 timepoints in this 16-day study."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male gender\n* Age ≥35\n* Current smoker of at least 10 cigarettes per day with history of ≥10 pack-years (py)\n* Former smoker, quit no more than 15 years ago with a history of at least 25 py\n* Ability to comply with the design of the study\n* Capacity to freeze urine sample at participant's residence if this participant desires to store the urine specimens in this manner\n* Baseline urine PGE-M \\> 13 ng/mg creatinine\n* Serum thromboxane \\> 150 μg/L\n\nExclusion Criteria:\n\n* History of aspirin use 1-14 days prior to screening\n* NSAID (ibuprofen, naprosyn, meloxicam, etc) use 1-7 days prior to screening\n* Inhaled glucocorticoid use 1-7 days prior to screening\n* Systemic glucocorticoid use 1-14 days prior to screening\n* History of peptic ulcer disease\n* Current or recent clinically significant bleeding\n* Allergy, intolerance or contraindication to aspirin or NSAID use\n* Thrombocytopenia (platelet count \\< 100,000) in 30 days prior to screening visit\n* Severe hepatic insufficiency\n* GFR \\< 30 mL/min/1.73 m2 in 30 days prior to screening visit\n* History of aspirin or celecoxib allergy\n* Elevated INR (\\>1.5) in 30 days prior to screening visit\n* Current diagnosis of malignancy or history of non-skin malignancy in last 5 years\n* Current use of systemic anticoagulants (e.g., warfarin (Coumadin), enoxaparin (Lovenox), Fondaparinux (Arixtra), dabigatran (Pradaxa))\n* Diagnosis of COPD\n* Intake of \\> 250 mg of fish oil supplementation daily"}, 'identificationModule': {'nctId': 'NCT01796951', 'briefTitle': 'Low Dose Aspirin Inhibition of COX-2 Derived PGE2 in Male Smokers', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Low Dose Aspirin Inhibition of COX-2 Derived PGE2 in Male Smokers', 'orgStudyIdInfo': {'id': 'VR5137'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Celecoxib, aspirin, followed by aspirin/celecoxib', 'description': 'Celecoxib 200 mg twice daily x3 days, aspirin 325 mg daily x10 days, celecoxib 200 mb twice daily + aspirin 325 mg daily x 3 days', 'interventionNames': ['Drug: Aspirin 325 mg daily', 'Drug: Celecoxib 200 mg BID']}], 'interventions': [{'name': 'Aspirin 325 mg daily', 'type': 'DRUG', 'description': 'In this single-arm trial, participants will take celecoxib 200 mg BID for 5 doses, followed by aspirin 325 mg daily for 10 days, followed by combination of celecoxib 200 mg BID for 5 doses and aspirin 325 mg daily for 3 days.', 'armGroupLabels': ['Celecoxib, aspirin, followed by aspirin/celecoxib']}, {'name': 'Celecoxib 200 mg BID', 'type': 'DRUG', 'description': 'In this single-arm trial, participants will take celecoxib 200 mg BID for 5 doses, followed by aspirin 325 mg daily for 10 days, followed by combination of celecoxib 200 mg BID for 5 doses and aspirin 325 mg daily for 3 days.', 'armGroupLabels': ['Celecoxib, aspirin, followed by aspirin/celecoxib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37212', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'John A Oates, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Vanderbilt University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Hematology/Oncology Clinical Fellow', 'investigatorFullName': 'Philip Lammers', 'investigatorAffiliation': 'Vanderbilt University'}}}}