Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT01973205
Status:
COMPLETED
Last Update Posted:
2015-06-11
First Post:
2013-10-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Acetaminophen and Aspirin Versus Placebo in the Acute Treatment of Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D001241', 'term': 'Aspirin'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '9735038000', 'title': 'Clinical Project Leader', 'organization': 'Novartis'}, 'certainAgreement': {'otherDetails': 'Sponsor shall review results communications prior to public release to evaluate the manuscript for accuracy, ascertain whether information (other than the results of the Clinical Trial) is being improperly disclosed, provided information which may have not have yet been made available by the Sponsor, provide input for consideration regarding the content and/or conclusion(s) of the manuscript and determine whether the manuscript discloses any potentially patentable invention(s).', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Number of participants analyzed includes only subjects who treated a migraine (AA: N=408, Placebo: N = 415)', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': '2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets\n\nPlacebo: 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets', 'otherNumAtRisk': 415, 'otherNumAffected': 0, 'seriousNumAtRisk': 415, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Acetaminophen 250 mg and Aspirin 250 mg', 'description': '2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg\n\nAcetaminophen 250 mg and Aspirin 250 mg: 2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg', 'otherNumAtRisk': 408, 'otherNumAffected': 0, 'seriousNumAtRisk': 408, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'intraductal profilerative breast lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 415, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 408, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects Who Are Pain Free at the 2-hour Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '415', 'groupId': 'OG000'}, {'value': '408', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets\n\nPlacebo: 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets'}, {'id': 'OG001', 'title': 'Acetaminophen 250 mg and Aspirin 250 mg', 'description': '2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg\n\nAcetaminophen 250 mg and Aspirin 250 mg: 2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 hours', 'description': 'Number of subjects who are pain free at the 2-hour assessment', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes only subjects who treated a migraine (AA: N=408, Placebo: N = 415) and had a non-missing pain free status at 2 hours (AA: N=408, Placebo: N = 415).'}, {'type': 'PRIMARY', 'title': 'Number of Subjects Who Are Nausea Free at the 2-hour Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '411', 'groupId': 'OG000'}, {'value': '403', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets\n\nPlacebo: 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets'}, {'id': 'OG001', 'title': 'Acetaminophen 250 mg and Aspirin 250 mg', 'description': '2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg\n\nAcetaminophen 250 mg and Aspirin 250 mg: 2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '208', 'groupId': 'OG000'}, {'value': '244', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 hours', 'description': 'Number of subjects who are nausea free at the 2-hour assessment', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes only subjects who treated a migraine (AA: N=408, Placebo: N=415) and had a non-missing nausea free status at 2 hours (AA: N=403, Placebo N= 411).'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Who Are Free of Photophobia at the 2-hour Assessment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '411', 'groupId': 'OG000'}, {'value': '403', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets\n\nPlacebo: 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets'}, {'id': 'OG001', 'title': 'Acetaminophen 250 mg and Aspirin 250 mg', 'description': '2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg\n\nAcetaminophen 250 mg and Aspirin 250 mg: 2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '116', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 hours', 'description': 'Number of subjects who are free of photophobia at the 2-hour assessment.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes only subjects who treated a migraine (AA: N=408, Placebo: N = 415) and had a non-missing photophobia free status at 2 hours (AA: N=403, Placebo: N = 411).'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Who Are Free of Phonophobia at the 2-hour Assessment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '411', 'groupId': 'OG000'}, {'value': '403', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets\n\nPlacebo: 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets'}, {'id': 'OG001', 'title': 'Acetaminophen 250 mg and Aspirin 250 mg', 'description': '2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg\n\nAcetaminophen 250 mg and Aspirin 250 mg: 2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 hours', 'description': 'Number of subjects who are free of phonophobia at the 2-hour assessment.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed includes only subjects who treated a migraine (AA: N=408, Placebo: N = 415) and had a non-missing phonophobia free status at 2 hours (AA: N=403, Placebo: N = 411).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': '2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets\n\nPlacebo: 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets'}, {'id': 'FG001', 'title': 'Acetaminophen 250 mg and Aspirin 250 mg', 'description': '2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg\n\nAcetaminophen 250 mg and Aspirin 250 mg: 2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '453'}, {'groupId': 'FG001', 'numSubjects': '447'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '423'}, {'groupId': 'FG001', 'numSubjects': '425'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '22'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '453', 'groupId': 'BG000'}, {'value': '447', 'groupId': 'BG001'}, {'value': '900', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': '2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets\n\nPlacebo: 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets'}, {'id': 'BG001', 'title': 'Acetaminophen 250 mg and Aspirin 250 mg', 'description': '2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg\n\nAcetaminophen 250 mg and Aspirin 250 mg: 2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.6', 'spread': '12.4', 'groupId': 'BG000'}, {'value': '39.7', 'spread': '12.8', 'groupId': 'BG001'}, {'value': '40.1', 'spread': '12.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '351', 'groupId': 'BG000'}, {'value': '350', 'groupId': 'BG001'}, {'value': '701', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '199', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '405', 'groupId': 'BG000'}, {'value': '399', 'groupId': 'BG001'}, {'value': '804', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '337', 'groupId': 'BG000'}, {'value': '318', 'groupId': 'BG001'}, {'value': '655', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '453', 'groupId': 'BG000'}, {'value': '447', 'groupId': 'BG001'}, {'value': '900', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 900}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-09', 'studyFirstSubmitDate': '2013-10-25', 'resultsFirstSubmitDate': '2015-05-20', 'studyFirstSubmitQcDate': '2013-10-25', 'lastUpdatePostDateStruct': {'date': '2015-06-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-06-09', 'studyFirstPostDateStruct': {'date': '2013-10-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects Who Are Pain Free at the 2-hour Assessment', 'timeFrame': '2 hours', 'description': 'Number of subjects who are pain free at the 2-hour assessment'}, {'measure': 'Number of Subjects Who Are Nausea Free at the 2-hour Assessment', 'timeFrame': '2 hours', 'description': 'Number of subjects who are nausea free at the 2-hour assessment'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects Who Are Free of Photophobia at the 2-hour Assessment.', 'timeFrame': '2 hours', 'description': 'Number of subjects who are free of photophobia at the 2-hour assessment.'}, {'measure': 'Number of Subjects Who Are Free of Phonophobia at the 2-hour Assessment.', 'timeFrame': '2 hours', 'description': 'Number of subjects who are free of phonophobia at the 2-hour assessment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Migraine', 'acetaminophen', 'aspirin'], 'conditions': ['Acute Migraine']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the efficacy and safety of acetaminophen and aspirin versus placebo in the acute treatment of migraine'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Male or female aged 18 years and over.\n2. International Headache Society (IHS) diagnosis of migraine without aura or typical aura with migraine headache.\n3. History of experiencing at least 1, but not more than 8, acute migraine attacks monthly during the previous year.\n4. History of at least moderate migraine pain intensity, if left untreated.\n5. History of frequently or always experiencing nausea with the migraine attack.\n\nExclusion criteria:\n\nSubjects eligible for inclusion in this study must not fulfill any of the following criteria:\n\n1. Headache symptoms which may be due to or aggravated by:\n\n * Recent (within 6 months) head or neck trauma (e.g., whiplash)\n * Head or neck pain secondary to an orthopedic abnormality\n * Cluster headache\n * Specific migraine variants (e.g., basilar-type artery migraine, opthalmoplegic migraine, hemiplegic migraine, migraine aura without headache)\n * Other serious, non-migraine causes of headache (e.g., increased intracranial pressure, intracranial bleeding, meningitis, malignancy)\n * Non-serious, non-migraine causes of headache (e.g., cold, flu, hangover)\n2. History of vomiting during more than 20% of migraine attacks.\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT01973205', 'briefTitle': 'Efficacy and Safety of Acetaminophen and Aspirin Versus Placebo in the Acute Treatment of Migraine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Multi-center, Randomized, Double-blind, Parallel-group, Single-dose, Placebo-controlled Study Comparing the Efficacy and Safety of a Combination of Acetaminophen and Aspirin vs Placebo in the Acute Treatment of Migraine', 'orgStudyIdInfo': {'id': '863-P-303'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Acetaminophen 250 mg and aspirin 250 mg', 'description': '2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg', 'interventionNames': ['Drug: Acetaminophen 250 mg and Aspirin 250 mg']}], 'interventions': [{'name': 'Acetaminophen 250 mg and Aspirin 250 mg', 'type': 'DRUG', 'description': '2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg', 'armGroupLabels': ['Acetaminophen 250 mg and aspirin 250 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'city': 'Jupiter', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.93422, 'lon': -80.09421}}, {'city': 'Oviedo', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.67, 'lon': -81.20812}}, {'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'city': 'Berlin', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 39.79123, 'lon': -74.92905}}, {'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'city': 'Williamsville', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 42.96395, 'lon': -78.73781}}, {'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'city': 'Mt. Pleasant', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}, {'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'city': 'Kenosha', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 42.58474, 'lon': -87.82119}}], 'overallOfficials': [{'name': 'Clinical Project Lead', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Consumer Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}