Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-02-27 @ 12:48 AM
Study NCT ID:
NCT01334957
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2011-04-12
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Surgical Surveillance Trial to Evaluate a Shortened Infusion Time of Intravenous Ibuprofen
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007052', 'term': 'Ibuprofen'}], 'ancestors': [{'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'arock@cumberlandpharma.com', 'phone': '615-255-0068', 'title': 'Dr. Amy Rock', 'organization': 'Cumberland Pharmaceuticals Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'During and after dosing with intravenous ibuprofen until 6 hours following the last dose of intravenous ibuprofen', 'eventGroups': [{'id': 'EG000', 'title': 'Intravenous Ibuprofen', 'description': 'Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period.\n\nIntravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes', 'otherNumAtRisk': 300, 'otherNumAffected': 49, 'seriousNumAtRisk': 300, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Infusion Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 34, 'numAffected': 34}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Anaemia Postoperative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}], 'seriousEvents': [{'term': 'Abdominal Compartment Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Peritoneal Adhesions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Bile Duct Stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Airway Complication Of Anaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Oxygen Saturation Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Urinary Retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'To Determine the Safety of a Single Dose of Intravenous Ibuprofen Over 5-10 Minutes for the Reduction of Pain.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Ibuprofen', 'description': 'Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period.\n\nIntravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 hours', 'description': 'The incidence of treatment-emergent serious adverse events occurring in the six hours following administration of the first dose of intravenous ibuprofen', 'unitOfMeasure': 'Number of Serious Adverse Events', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Ibuprofen', 'description': 'Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period.\n\nIntravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 hours', 'description': 'The incidence of treatment-emergent adverse events occurring in the six hours following administration of the first dose of intravenous ibuprofen', 'unitOfMeasure': 'Number of Adverse Events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Over 5-10 Minutes for the Reduction of Pain.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Ibuprofen', 'description': 'Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period.\n\nIntravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 hours', 'description': 'The incidence of treatment-emergent serious adverse events occurring in the six hours following administration of the last dose of intravenous ibuprofen', 'unitOfMeasure': 'Number of Serious Adverse Events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Ibuprofen', 'description': 'Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period.\n\nIntravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 hours', 'description': 'The incidence of treatment-emergent adverse events occurring in the six hours following administration of the last dose of intravenous ibuprofen', 'unitOfMeasure': 'Number of Adverse Events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intravenous Ibuprofen', 'description': 'Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period.\n\nIntravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '30.9', 'groupId': 'OG000', 'lowerLimit': '27.5', 'upperLimit': '34.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 hours', 'description': 'Visual Analog Scale (VAS) assessments following surgery. The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the "No Pain" anchor and the subject\'s mark. The score would be between o and 100.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intravenous Ibuprofen', 'description': 'Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period. A minimum of one dose of intravenous ibuprofen will be administered. At the discretion of the investigator, up to three additional doses of 800 mg intravenous ibuprofen may be administered at six hour intervals.\n\nIntravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '300'}]}, {'type': 'Received Single Dose', 'achievements': [{'groupId': 'FG000', 'numSubjects': '252'}]}, {'type': 'Received Multiple Doses', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '300'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Adult hospitalized patients undergoing surgery', 'preAssignmentDetails': 'Patients who met all the inclusion and none of the exclusion criteria during the Screening /Baseline Period were enrolled into the study.\n\nSubjects could not have a history of allergy or hypersensitivity to any component of intravenous ibuprofen, aspirin (or aspirin related products) or NSAIDS.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Intravenous Ibuprofen', 'description': 'Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period.\n\nIntravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Greater than or equal to 18 years of age', 'categories': [{'measurements': [{'value': '300', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Greater than or equal to 18 years of age', 'unitOfMeasure': 'years'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '189', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '111', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '271', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '60', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '229', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '300', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Formal sample size calculations were not performed. The intent is to enroll 300 patients to provide descriptive safety and efficacy data.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-05', 'studyFirstSubmitDate': '2011-04-12', 'resultsFirstSubmitDate': '2014-04-15', 'studyFirstSubmitQcDate': '2011-04-12', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-05-20', 'studyFirstPostDateStruct': {'date': '2011-04-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To Determine the Safety of a Single Dose of Intravenous Ibuprofen Over 5-10 Minutes for the Reduction of Pain.', 'timeFrame': '6 hours', 'description': 'The incidence of treatment-emergent serious adverse events occurring in the six hours following administration of the first dose of intravenous ibuprofen'}, {'measure': 'To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain.', 'timeFrame': '6 hours', 'description': 'The incidence of treatment-emergent adverse events occurring in the six hours following administration of the first dose of intravenous ibuprofen'}], 'secondaryOutcomes': [{'measure': 'To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Over 5-10 Minutes for the Reduction of Pain.', 'timeFrame': '6 hours', 'description': 'The incidence of treatment-emergent serious adverse events occurring in the six hours following administration of the last dose of intravenous ibuprofen'}, {'measure': 'To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain.', 'timeFrame': '6 hours', 'description': 'The incidence of treatment-emergent adverse events occurring in the six hours following administration of the last dose of intravenous ibuprofen'}, {'measure': 'To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain.', 'timeFrame': '6 hours', 'description': 'Visual Analog Scale (VAS) assessments following surgery. The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the "No Pain" anchor and the subject\'s mark. The score would be between o and 100.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '25592331', 'type': 'DERIVED', 'citation': 'Gan TJ, Candiotti K, Turan A, Buvanendran A, Philip BK, Viscusi ER, Soghomonyan S, Bergese SD; Intravenous Ibuprofen Surgical Surveillance Trial Investigational Sites. The shortened infusion time of intravenous ibuprofen, part 2: a multicenter, open-label, surgical surveillance trial to evaluate safety. Clin Ther. 2015 Feb 1;37(2):368-75. doi: 10.1016/j.clinthera.2014.12.006. Epub 2015 Jan 13.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to determine the safety of a single dose of intravenous ibuprofen administered over 5-10 minutes for the preemptive treatment of postoperative pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for surgery with anticipated need for postoperative analgesia\n\nExclusion Criteria:\n\n1. Patients with inadequate IV access\n2. Patients \\<18 years of age\n3. History or allergy or hypersensitivity to any component of intravenous ibuprofen, aspirin (or aspirin related products) or non-steroidal anti-inflammatory drug (NSAIDs)\n4. Active hemorrhage or clinically significant bleeding\n5. Pregnant or nursing\n6. Patients in the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery\n7. Inability to understand the requirements of the study, be willing to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board \\[IRB\\]), and agree to abide by the study restrictions\n8. Refusal to provide written authorization for use and disclosure of protected health information'}, 'identificationModule': {'nctId': 'NCT01334957', 'briefTitle': 'Surgical Surveillance Trial to Evaluate a Shortened Infusion Time of Intravenous Ibuprofen', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cumberland Pharmaceuticals'}, 'officialTitle': 'A Multi-Center, Open-Label, Surgical Surveillance Trial To Evaluate The Safety And Efficacy Of A Shortened Infusion Time of Intravenous Ibuprofen', 'orgStudyIdInfo': {'id': 'CPI-CL-016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intravenous ibuprofen', 'description': 'Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period.', 'interventionNames': ['Drug: Intravenous ibuprofen']}], 'interventions': [{'name': 'Intravenous ibuprofen', 'type': 'DRUG', 'otherNames': ['Caldolor'], 'description': '800 mg intravenous ibuprofen administered intravenously over 5-10 minutes', 'armGroupLabels': ['Intravenous ibuprofen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'UC San Diego Regional Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '94558', 'city': 'Napa', 'state': 'California', 'country': 'United States', 'facility': 'Neurovations (Queen of the Valley Hospital)', 'geoPoint': {'lat': 38.29714, 'lon': -122.28553}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Health System', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33324', 'city': 'Plantation', 'state': 'Florida', 'country': 'United States', 'facility': 'Sheridan Clinical Research', 'geoPoint': {'lat': 26.13421, 'lon': -80.23184}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'RUSH Univ. Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'Univ. of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '70121-2483', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Ochsner Medical Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Detroit Medical Center', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '38801', 'city': 'Tupelo', 'state': 'Mississippi', 'country': 'United States', 'facility': 'North Mississippi Sports Medicine & Orthopaedic Clinic', 'geoPoint': {'lat': 34.25807, 'lon': -88.70464}}, {'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Albany Medical Center', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '11203', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'State of New York Downstate Medical Center (SUNY)', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'North Shore - Long Island Jewish Health System', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'The University of North Carolina at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Health System', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest Baptist Medical Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43201', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State College of Medicine', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37075', 'city': 'Hendersonville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Hendersonville Hospital/Comprehensive Pain Specialists', 'geoPoint': {'lat': 36.30477, 'lon': -86.62}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Parkland Memorial', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Art P Wheeler, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cumberland Pharmaceuticals, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cumberland Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}