Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2026-02-23 @ 1:53 PM
Study NCT ID:
NCT00624559
Status:
COMPLETED
Last Update Posted:
2012-01-06
First Post:
2008-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Role of COX-2 Inhibition in Salt Sensitivity of Blood Pressure
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068579', 'term': 'Celecoxib'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'wbf@udel.edu', 'phone': '302-831-6178', 'title': 'Dr. William Farquhar', 'organization': 'University of Delaware'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Celebrex, High Sodium', 'description': "Each subject completes a normal sodium diet (3 days), a high salt diet (7 days), and a low salt diet (7 days) while taking either a placebo or celebrex (each trial is 17 days long). Each subject completes 2 full 17 day trials (one month 'washout' between each trial); one time taking the placebo and one taking celebrex (randomized).", 'otherNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Celebrex, Low Sodium', 'description': '100 mg Celebrex, twice per day for 7 days on low sodium diet', 'otherNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo, Low Sodium', 'description': 'Placebo pill taken twice per day over the course of the diet', 'otherNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo, High Sodium', 'description': 'Placebo pill taken twice per day over the course of the diet', 'otherNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Arterial Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Celebrex, Low Sodium Diet', 'description': 'Result taken at the end of 7 day low sodium diet'}, {'id': 'OG001', 'title': 'Celebrex, High Sodium Diet', 'description': 'Result taken on last day of a 7 day high salt diet'}, {'id': 'OG002', 'title': 'Placebo, Low Sodium Diet', 'description': 'Blood pressure taken over 24 hours on the last day of the low sodium diet with and ambulatory blood pressure monitor'}, {'id': 'OG003', 'title': 'Placebo, High Sodium Diet', 'description': 'Blood pressure taken with an ambulatory blood pressure monitor, over 24 hours on the last day of the high sodium diet'}], 'classes': [{'categories': [{'measurements': [{'value': '88', 'spread': '2', 'groupId': 'OG000'}, {'value': '87', 'spread': '2', 'groupId': 'OG001'}, {'value': '87', 'spread': '2', 'groupId': 'OG002'}, {'value': '87', 'spread': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'description': 'Blood pressure was measured on the last day of each 7 day sodium diet for 24 hours using an ambulatory blood pressure monitor', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Urinary Sodium Excretion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Celebrex, Low Sodium Diet', 'description': 'Result taken at the end of 7 day low sodium diet'}, {'id': 'OG001', 'title': 'Celebrex, High Sodium Diet', 'description': 'Result taken on last day of a 7 day high salt diet'}, {'id': 'OG002', 'title': 'Placebo, Low Sodium Diet', 'description': 'Blood pressure taken over 24 hours on the last day of the low sodium diet with and ambulatory blood pressure monitor'}, {'id': 'OG003', 'title': 'Placebo, High Sodium Diet', 'description': 'Blood pressure taken with an ambulatory blood pressure monitor, over 24 hours on the last day of the high sodium diet'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'spread': '7', 'groupId': 'OG000'}, {'value': '281', 'spread': '27', 'groupId': 'OG001'}, {'value': '14', 'spread': '3', 'groupId': 'OG002'}, {'value': '253', 'spread': '10', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hour', 'description': 'Urine collected over 24 hour period on last day of each different sodium diet', 'unitOfMeasure': 'mmol Na+/24 hr', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Celebrex, High Sodium', 'description': "Each subject completes a normal sodium diet (3 days), a high salt diet (7 days), and a low salt diet (7 days) while taking either a placebo or celebrex (each trial is 17 days long). Each subject completes 2 full 17 day trials (one month 'washout' between each trial); one time taking the placebo and one taking celebrex (randomized)."}, {'id': 'FG001', 'title': 'Celebrex, Low Sodium', 'description': '100 mg Celebrex, twice per day for 7 days on low sodium diet'}, {'id': 'FG002', 'title': 'Placebo, Low Sodium', 'description': 'Placebo pill taken twice per day over the course of the diet'}, {'id': 'FG003', 'title': 'Placebo, High Sodium', 'description': 'Placebo pill taken twice per day over the course of the diet'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Celebrex 1st: 3days baseline(100mmol), 7days high(350mmol) followed by 7days low(20mmol) sodium/day', 'groupId': 'FG000', 'numSubjects': '3'}, {'comment': 'Celebrex 1st: 3days baseline(100mmol), 7days low(20mmol) followed by 7days high(350mmol) sodium/day', 'groupId': 'FG001', 'numSubjects': '3'}, {'comment': 'Placebo 1st: 3days baseline(100mmol), 7days low(20mmol) followed by 7days high(350mmol) sodium/day', 'groupId': 'FG002', 'numSubjects': '3'}, {'comment': 'Placebo 1st: 3days baseline(100mmol), 7days high(350mmol) followed by 7days low(20mmol) sodium/day', 'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Celebrex, High Sodium', 'description': "Each subject completes a normal sodium diet (3 days), a high salt diet (7 days), and a low salt diet (7 days) while taking either a placebo or celebrex (each trial is 17 days long). Each subject completes 2 full 17 day trials (one month 'washout' between each trial); one time taking the placebo and one taking celebrex (randomized)."}, {'id': 'BG001', 'title': 'Celebrex, Low Sodium', 'description': '100 mg Celebrex, twice per day for 7 days on low sodium diet'}, {'id': 'BG002', 'title': 'Placebo, Low Sodium', 'description': 'Placebo pill taken twice per day over the course of the diet'}, {'id': 'BG003', 'title': 'Placebo, High Sodium', 'description': 'Placebo pill taken twice per day over the course of the diet'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35', 'spread': '2', 'groupId': 'BG000'}, {'value': '35', 'spread': '2', 'groupId': 'BG001'}, {'value': '35', 'spread': '2', 'groupId': 'BG002'}, {'value': '35', 'spread': '2', 'groupId': 'BG003'}, {'value': '35', 'spread': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-04', 'studyFirstSubmitDate': '2008-02-15', 'resultsFirstSubmitDate': '2011-08-17', 'studyFirstSubmitQcDate': '2008-02-15', 'lastUpdatePostDateStruct': {'date': '2012-01-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-11-16', 'studyFirstPostDateStruct': {'date': '2008-02-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Arterial Pressure', 'timeFrame': '24 hours', 'description': 'Blood pressure was measured on the last day of each 7 day sodium diet for 24 hours using an ambulatory blood pressure monitor'}], 'secondaryOutcomes': [{'measure': 'Urinary Sodium Excretion', 'timeFrame': '24 hour', 'description': 'Urine collected over 24 hour period on last day of each different sodium diet'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Salt sensitivity of Blood Pressure'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if the drug Celebrex changes the way the kidney gets rid of salt and maintains blood pressure.', 'detailedDescription': 'There have been many studies done with analgesics such as acetaminophen and non-steroidal anti-inflammatory drugs; however it is not understood how blood pressure changes while using Celebrex. The study hypothesis is that Celebrex will increase salt sensitivity of blood pressure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '22 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy men and women\n\nExclusion Criteria:\n\n* history of heart disease\n* have had heart surgery\n* high blood pressure\n* diabetes\n* cancer\n* any other disease such as kidney or neurological diseases\n* taking medications such as aspirin or medicines for your heart or blood pressure\n* have asthma or are allergic to sulfa drugs\n* body mass index greater than 30\n* use tobacco\n* pregnant\n* women using oral contraceptives or hormone replacement therapy'}, 'identificationModule': {'nctId': 'NCT00624559', 'briefTitle': 'The Role of COX-2 Inhibition in Salt Sensitivity of Blood Pressure', 'organization': {'class': 'OTHER', 'fullName': 'University of Delaware'}, 'officialTitle': 'COX-2 Regulation of Renal Sodium Handling in Blood Pressure Maintenance', 'orgStudyIdInfo': {'id': '134024-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Celebrex; Low sodium', 'description': 'Subject completes a normal sodium diet (3 days), a low salt diet (7 days), followed by a high salt diet (7 days) while taking a celebrex pill (100 mg twice a day for 17 day trial), randomized for trial order (drug versus placebo) and sodium diet order (low versus high sodium).', 'interventionNames': ['Drug: celecoxib (Celebrex)']}, {'type': 'EXPERIMENTAL', 'label': 'Celebrex, High Sodium', 'description': 'Subject completes a normal sodium diet (3 days), a high salt diet (7 days), followed by a low salt diet (7 days) while taking a celebrex pill (100 mg twice a day for 17 day trial), randomized for trial order (drug versus placebo) and sodium diet order (low versus high sodium).', 'interventionNames': ['Drug: celecoxib (Celebrex)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo, Low Sodium', 'description': 'Subject completes a normal sodium diet (3 days), a low salt diet (7 days), followed by a high salt diet (7 days) while taking a placebo pill (twice a day for 17 day trial), randomized for trial order (drug versus placebo) and sodium diet order (low versus high sodium).', 'interventionNames': ['Other: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo, High Sodium', 'description': 'Subject completes a normal sodium diet (3 days), a high salt diet (7 days), followed by a low salt diet (7 days) while taking a placebo pill (twice a day for 17 day trial), randomized for trial order (drug versus placebo) and sodium diet order (low versus high sodium).', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'celecoxib (Celebrex)', 'type': 'DRUG', 'otherNames': ['Celebrex'], 'description': 'Celecoxib (Celebrex) was administered at 100 mg, twice per day for each day of sodium diet', 'armGroupLabels': ['Celebrex, High Sodium', 'Celebrex; Low sodium']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo pill taken twice per day on each day of the diet', 'armGroupLabels': ['Placebo, High Sodium', 'Placebo, Low Sodium']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19716', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'University of Delaware', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}], 'overallOfficials': [{'name': 'William B Farquhar, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Delaware'}, {'name': 'Michael Stillabower, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Christiana Care Health Services'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Delaware', 'class': 'OTHER'}, 'collaborators': [{'name': 'Christiana Care Health Services', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor and Department Chair, KAAP', 'investigatorFullName': 'William Farquhar', 'investigatorAffiliation': 'University of Delaware'}}}}