Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2026-01-03 @ 3:00 AM
Study NCT ID:
NCT00410995
Status:
TERMINATED
Last Update Posted:
2007-10-11
First Post:
2006-12-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Naproxen on Physical Performance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009288', 'term': 'Naproxen'}], 'ancestors': [{'id': 'D009280', 'term': 'Naphthaleneacetic Acids'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 40}}, 'statusModule': {'whyStopped': 'Study never initiated.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-10', 'completionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-10-10', 'studyFirstSubmitDate': '2006-12-12', 'studyFirstSubmitQcDate': '2006-12-12', 'lastUpdatePostDateStruct': {'date': '2007-10-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-12-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effects on physical performance in terms of maximum oxygen consumption'}]}, 'conditionsModule': {'keywords': ['Physically fit volunteers'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effect of daily use of Naproxen (a commonly used over-the-counter NSAID) on the physical performance of athletes, as measured by maximum oxygen consumption.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age equal to or greater than18 years of age\n2. No history of allergy or adverse reaction to any NSAID\n3. No use of any NSAID in past 2 weeks\n4. No history of peptic ulcer disease (PUD), gastroesophageal disease (GERD), or gastritis\n5. No major medical history including but not limited to diabetes, hypertension, asthma, kidney disease and coronary artery disease\n6. Currently not taking any medication including oral contraceptives\n\nExclusion Criteria:\n\n1. Age \\< 18 years of age\n2. History of allergy or adverse reaction to any NSAID\n3. Use of any NSAID in past 2 weeks\n4. History of a bleeding disorder\n5. History of PUD, GERD, or gastritis\n6. Pregnant\n7. A medical history of diabetes, hypertension, asthma, kidney disease or coronary artery disease\n8. Taking any medication including oral contraceptives'}, 'identificationModule': {'nctId': 'NCT00410995', 'briefTitle': 'Effects of Naproxen on Physical Performance', 'organization': {'class': 'OTHER', 'fullName': 'University of Oklahoma'}, 'officialTitle': 'Effects of Naproxen on Physical Performance', 'orgStudyIdInfo': {'id': '11186'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Naproxen', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '74104', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Family Practice - CMT', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}], 'overallOfficials': [{'name': 'LaMont Cavanagh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oklahoma-Tulsa'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oklahoma', 'class': 'OTHER'}}}}