Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2025-12-27 @ 9:18 AM
Study NCT ID:
NCT01248468
Status:
COMPLETED
Last Update Posted:
2012-07-30
First Post:
2010-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Acetaminophen, Aspirin and Caffeine With Sumatriptan in the Acute Treatment of Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'C110820', 'term': 'acetaminophen, aspirin, caffeine drug combination'}, {'id': 'D018170', 'term': 'Sumatriptan'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D014363', 'term': 'Tryptamines'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '973-503-8000', 'title': 'Clinical Project Leader', 'organization': 'Novartis Consumer Health'}, 'certainAgreement': {'otherDetails': 'Data of \\&/or resulting from the performance of the Clinical Trial (CT) shall be pooled with the data from other centers \\& analyzed as stipulated in the Protocol.Without the consent of the steering committee of the multi-center CT, no presentation/publication of the results obtained from datasets other than the final pooled dataset shall be made prior to the presentation/ publication based on the final pooled dataset.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Aspirin, Acetaminophen, and Caffeine', 'description': '2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets', 'otherNumAtRisk': 266, 'otherNumAffected': 8, 'seriousNumAtRisk': 266, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sumatriptan (100 mg)', 'description': '1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets', 'otherNumAtRisk': 271, 'otherNumAffected': 14, 'seriousNumAtRisk': 271, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': '1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets', 'otherNumAtRisk': 133, 'otherNumAffected': 3, 'seriousNumAtRisk': 133, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 271, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 133, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent of Subjects Who Are Pain Free at 2 Hours.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aspirin, Acetaminophen, and Caffeine', 'description': '2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets'}, {'id': 'OG001', 'title': 'Sumatriptan (100 mg)', 'description': '1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets'}, {'id': 'OG002', 'title': 'Placebo', 'description': '1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '34.7', 'groupId': 'OG000', 'lowerLimit': '.938', 'upperLimit': '2.484'}, {'value': '44.9', 'groupId': 'OG001', 'lowerLimit': '0.431', 'upperLimit': '.900'}, {'value': '26.4', 'groupId': 'OG002', 'lowerLimit': '1.525', 'upperLimit': '3.937'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 hours', 'description': 'Subjects assessed severity of pain on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of pain=none at 2 hours were considered pain free at 2 hours', 'unitOfMeasure': 'Percent of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The basic population for efficacy analysis was ITT. No explicit process to impute missing values at any given assessment timepoint. Instead, missing values were implicitly imputed by the repeated measures analysis statistical model. So, at any given timepoint, the number of subjects analyzed is slightly less than the total ITT population.'}, {'type': 'SECONDARY', 'title': 'Percent of Subjects Who Are Free of Nausea at 2 Hours.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '252', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aspirin, Acetaminophen, and Caffeine', 'description': '2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets'}, {'id': 'OG001', 'title': 'Sumatriptan (100 mg)', 'description': '1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets'}, {'id': 'OG002', 'title': 'Placebo', 'description': '1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '70.6', 'groupId': 'OG000', 'lowerLimit': '.863', 'upperLimit': '2.522'}, {'value': '72.2', 'groupId': 'OG001', 'lowerLimit': '.662', 'upperLimit': '1.506'}, {'value': '66.4', 'groupId': 'OG002', 'lowerLimit': '.856', 'upperLimit': '2.549'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 hours', 'description': 'Subjects assessed severity of relevant symptom on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of relevant symptom=none at 2 hours were considered relevant symptom free at 2 hours', 'unitOfMeasure': 'percent of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The basic population for efficacy analysis was ITT. No explicit process to impute missing values at any given assessment timepoint. Missing values were implicitly imputed by the repeated measures analysis statistical model. Consequently, at any given timepoint, the number of subjects analyzed is slightly less than the total ITT population.'}, {'type': 'SECONDARY', 'title': 'Percent of Subjects Who Are Free of Phonophobia at 2 Hours.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aspirin, Acetaminophen, and Caffeine', 'description': '2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets'}, {'id': 'OG001', 'title': 'Sumatriptan (100 mg)', 'description': '1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets'}, {'id': 'OG002', 'title': 'Placebo', 'description': '1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '53.4', 'groupId': 'OG000', 'lowerLimit': '.904', 'upperLimit': '2.353'}, {'value': '60.9', 'groupId': 'OG001', 'lowerLimit': '.630', 'upperLimit': '1.334'}, {'value': '46.2', 'groupId': 'OG002', 'lowerLimit': '.977', 'upperLimit': '2.590'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 hours', 'description': 'Subjects assessed severity of relevant symptom on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of relevant symptom=none at 2 hours were considered relevant symptom free at 2 hours', 'unitOfMeasure': 'Percent of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The basic population for efficacy analysis was ITT. No explicit process to impute missing values at any given assessment timepoint. Missing values were implicitly imputed by the repeated measures analysis statistical model. Consequently, at any given timepoint, the number of subjects analyzed is slightly less than the total ITT population.'}, {'type': 'SECONDARY', 'title': 'Percent of Subjects Who Are Free of Photophobia at 2 Hours.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aspirin, Acetaminophen, and Caffeine', 'description': '2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets'}, {'id': 'OG001', 'title': 'Sumatriptan (100 mg)', 'description': '1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets'}, {'id': 'OG002', 'title': 'Placebo', 'description': '1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '48.6', 'groupId': 'OG000', 'lowerLimit': '.888', 'upperLimit': '2.327'}, {'value': '52.3', 'groupId': 'OG001', 'lowerLimit': '.631', 'upperLimit': '1.315'}, {'value': '40.8', 'groupId': 'OG002', 'lowerLimit': '.980', 'upperLimit': '2.542'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 hours', 'description': 'Subjects assessed severity of relevant symptom on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of relevant symptom=none at 2 hours were considered relevant symptom free at 2 hours', 'unitOfMeasure': 'Percent of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aspirin, Acetaminophen, and Caffeine', 'description': '2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets'}, {'id': 'FG001', 'title': 'Sumatriptan (100 mg)', 'description': '1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets'}, {'id': 'FG002', 'title': 'Placebo', 'description': '1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '299'}, {'groupId': 'FG001', 'numSubjects': '304'}, {'groupId': 'FG002', 'numSubjects': '149'}]}, {'type': 'Safety Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '266'}, {'groupId': 'FG001', 'numSubjects': '271'}, {'groupId': 'FG002', 'numSubjects': '133'}]}, {'type': 'ITT Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '256'}, {'groupId': 'FG001', 'numSubjects': '261'}, {'groupId': 'FG002', 'numSubjects': '125'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '284'}, {'groupId': 'FG001', 'numSubjects': '290'}, {'groupId': 'FG002', 'numSubjects': '145'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Administrative problem', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'BG000'}, {'value': '304', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '752', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Aspirin, Acetaminophen, and Caffeine', 'description': '2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets'}, {'id': 'BG001', 'title': 'Sumatriptan (100 mg)', 'description': '1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets'}, {'id': 'BG002', 'title': 'Placebo', 'description': '1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38', 'spread': '11.4', 'groupId': 'BG000'}, {'value': '37.8', 'spread': '11.4', 'groupId': 'BG001'}, {'value': '37.6', 'spread': '11.5', 'groupId': 'BG002'}, {'value': '37.8', 'spread': '11.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '250', 'groupId': 'BG000'}, {'value': '245', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}, {'value': '620', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '132', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '115', 'groupId': 'BG003'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '244', 'groupId': 'BG000'}, {'value': '239', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}, {'value': '596', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}]}, {'title': 'Unknown or Not Reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Calculation for randomized subjects', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '299', 'groupId': 'BG000'}, {'value': '304', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '752', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 752}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-22', 'studyFirstSubmitDate': '2010-11-23', 'resultsFirstSubmitDate': '2012-03-22', 'studyFirstSubmitQcDate': '2010-11-24', 'lastUpdatePostDateStruct': {'date': '2012-07-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-06-22', 'studyFirstPostDateStruct': {'date': '2010-11-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of Subjects Who Are Pain Free at 2 Hours.', 'timeFrame': '2 hours', 'description': 'Subjects assessed severity of pain on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of pain=none at 2 hours were considered pain free at 2 hours'}], 'secondaryOutcomes': [{'measure': 'Percent of Subjects Who Are Free of Nausea at 2 Hours.', 'timeFrame': '2 hours', 'description': 'Subjects assessed severity of relevant symptom on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of relevant symptom=none at 2 hours were considered relevant symptom free at 2 hours'}, {'measure': 'Percent of Subjects Who Are Free of Phonophobia at 2 Hours.', 'timeFrame': '2 hours', 'description': 'Subjects assessed severity of relevant symptom on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of relevant symptom=none at 2 hours were considered relevant symptom free at 2 hours'}, {'measure': 'Percent of Subjects Who Are Free of Photophobia at 2 Hours.', 'timeFrame': '2 hours', 'description': 'Subjects assessed severity of relevant symptom on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of relevant symptom=none at 2 hours were considered relevant symptom free at 2 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pain, Migraine'], 'conditions': ['Pain, Migraine']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to compare the efficacy and safety of aspirin, acetaminophen and caffeine (AAC) with sumatriptan and 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.\n\nExclusion 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, ophthalmoplegic 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. Routine use (≥ 10 days per month, on average) of any medication having the potential to interfere with the pharmacologic effects or evaluation of the study medications (e.g., narcotic and non-narcotic analgesic products (prescription or over-the-counter), ergotamine-containing and ergot-type medication, anxiolytics, hypnotics, sedatives, 5HT-1 agonists, anti-emetics, or prokinetic drugs).\n3. History of vomiting during more than 20% of migraine episodes or confined to bedrest for more than 50% of migraine episodes.\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT01248468', 'briefTitle': 'Efficacy and Safety of Acetaminophen, Aspirin and Caffeine With Sumatriptan 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 Acetaminophen, Aspirin and Caffeine With Sumatriptan in the Acute Treatment of Migraine.', 'orgStudyIdInfo': {'id': '176-P-401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aspirin, acetaminophen and caffeine', 'description': 'AAC: 2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets', 'interventionNames': ['Drug: Aspirin, acetaminophen and caffeine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sumatriptan (100 mg)', 'description': '1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets', 'interventionNames': ['Drug: Sumatriptan']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Aspirin, acetaminophen and caffeine', 'type': 'DRUG', 'description': '2 tablets each containing Aspirin (250mg), acetaminophen (250mg) and caffeine (65mg)', 'armGroupLabels': ['Aspirin, acetaminophen and caffeine']}, {'name': 'Sumatriptan', 'type': 'DRUG', 'description': '100 mg Sumatriptan', 'armGroupLabels': ['Sumatriptan (100 mg)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'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': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'city': 'DeLand', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.02832, 'lon': -81.30312}}, {'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'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': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'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': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Clinical Project Leader', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Consumer Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}