Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-01-05 @ 6:23 PM
Study NCT ID:
NCT03173456
Status:
COMPLETED
Last Update Posted:
2022-02-01
First Post:
2017-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparing Five Oral Analgesics for Treatment of Acute Pain in the Emergency Department (ED)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D059352', 'term': 'Musculoskeletal Pain'}, {'id': 'D059787', 'term': 'Acute Pain'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C514822', 'term': 'oxycodone-acetaminophen'}, {'id': 'C083640', 'term': 'acetaminophen, hydrocodone drug combination'}, {'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D007052', 'term': 'Ibuprofen'}], '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': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'polly.bijur@einsteinmed.org', 'phone': '914-661-4707', 'title': 'Dr. Polly Bijur', 'organization': 'Department of Emergency Medicine Albert Einstein Coll of Med'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '2 hours', 'eventGroups': [{'id': 'EG000', 'title': '400 Ibuprofen/APAP', 'description': '400 mg ibuprofen + 1000 mg acetaminophen\n\n400 ibuprofen/APAP: ibuprofen/acetaminophen 400 mg-1000mg oral tablet', 'otherNumAtRisk': 120, 'deathsNumAtRisk': 120, 'otherNumAffected': 0, 'seriousNumAtRisk': 120, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '800 Ibuprofen/APAP', 'description': '800 mg ibuprofen + 1000 mg acetaminophen\n\n800 ibuprofen/APAP: ibuprofen/acetaminophen 800 mg-1000 mg oral tablet', 'otherNumAtRisk': 118, 'deathsNumAtRisk': 118, 'otherNumAffected': 0, 'seriousNumAtRisk': 118, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Codeine/APAP', 'description': '30 mg codeine + 300 mg acetaminophen\n\ncodeine/APAP: Codeine/acetaminophen 30 mg-300mg oral tablet', 'otherNumAtRisk': 120, 'deathsNumAtRisk': 120, 'otherNumAffected': 0, 'seriousNumAtRisk': 120, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Hydrocodone/APAP', 'description': '5 mg hydrocodone + 300 mg acetaminophen\n\nhydrocodone/APAP: Hydrocodone/Acetaminophen 5 Mg-300 Mg oral tablet', 'otherNumAtRisk': 119, 'deathsNumAtRisk': 119, 'otherNumAffected': 0, 'seriousNumAtRisk': 119, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Oxycodone/APAP', 'description': '5 mg oxycodone + 325 mg acetaminophen\n\noxycodone/APAP: Oxycodone/acetaminophen 5 mg-325 mg oral tablet', 'otherNumAtRisk': 120, 'deathsNumAtRisk': 120, 'otherNumAffected': 0, 'seriousNumAtRisk': 120, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Pain From Before Medication Administered (Baseline) to One-hour Post-baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}, {'value': '119', 'groupId': 'OG003'}, {'value': '120', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '400 Ibuprofen/APAP', 'description': '400 mg ibuprofen + 1000 mg acetaminophen\n\n400 ibuprofen/APAP: ibuprofen/acetaminophen 400 mg-1000mg oral tablet'}, {'id': 'OG001', 'title': '800 Ibuprofen/APAP', 'description': '800 mg ibuprofen + 1000 mg acetaminophen\n\n800 ibuprofen/APAP: ibuprofen/acetaminophen 800 mg-1000 mg oral tablet'}, {'id': 'OG002', 'title': 'Codeine/APAP', 'description': '30 mg codeine + 300 mg acetaminophen\n\ncodeine/APAP: Codeine/acetaminophen 30 mg-300mg oral tablet'}, {'id': 'OG003', 'title': 'Hydrocodone/APAP', 'description': '5 mg hydrocodone + 300 mg acetaminophen\n\nhydrocodone/APAP: Hydrocodone/Acetaminophen 5 Mg-300 Mg oral tablet'}, {'id': 'OG004', 'title': 'Oxycodone/APAP', 'description': '5 mg oxycodone + 325 mg acetaminophen\n\noxycodone/APAP: Oxycodone/acetaminophen 5 mg-325 mg oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '2.6', 'upperLimit': '3.5'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '2.5', 'upperLimit': '3.5'}, {'value': '3.4', 'groupId': 'OG002', 'lowerLimit': '2.9', 'upperLimit': '3.9'}, {'value': '3.1', 'groupId': 'OG003', 'lowerLimit': '2.7', 'upperLimit': '3.5'}, {'value': '3.3', 'groupId': 'OG004', 'lowerLimit': '2.8', 'upperLimit': '3.7'}]}]}], 'analyses': [{'pValue': '0.69', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'A priori threshold for statistical significance was 0.05. The plan was to only do individual comparisons between means if the overall test of the analysis of variance (AVOVA) was statistically significant', 'groupDescription': 'The null hypothesis is that all means are equal. The alternate hypothesis is that one or more mean is less than or more than another.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Prior to Ingestion of study medication to one hour after ingestion of the study medication', 'description': 'Pain intensity measured by 11-point Numerical Rating Scale (NRS) of Pain 0 = no pain 10 = worse possible pain. Change calculated as NRS before medication administered (denoted as baseline) minus NRS 1-hour post-baseline. Higher scores mean more change which is the better outcome.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Pain From Before Medication Administered (Baseline) to Two Hour Post-baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}, {'value': '117', 'groupId': 'OG003'}, {'value': '120', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '400 Ibuprofen/APAP', 'description': '400 mg ibuprofen + 1000 mg acetaminophen\n\n400 ibuprofen/APAP: ibuprofen/acetaminophen 400 mg-1000mg oral tablet'}, {'id': 'OG001', 'title': '800 Ibuprofen/APAP', 'description': '800 mg ibuprofen + 1000 mg acetaminophen\n\n800 ibuprofen/APAP: ibuprofen/acetaminophen 800 mg-1000 mg oral tablet'}, {'id': 'OG002', 'title': 'Codeine/APAP', 'description': '30 mg codeine + 300 mg acetaminophen\n\ncodeine/APAP: Codeine/acetaminophen 30 mg-300mg oral tablet'}, {'id': 'OG003', 'title': 'Hydrocodone/APAP', 'description': '5 mg hydrocodone + 300 mg acetaminophen\n\nhydrocodone/APAP: Hydrocodone/Acetaminophen 5 Mg-300 Mg oral tablet'}, {'id': 'OG004', 'title': 'Oxycodone/APAP', 'description': '5 mg oxycodone + 325 mg acetaminophen\n\noxycodone/APAP: Oxycodone/acetaminophen 5 mg-325 mg oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000', 'lowerLimit': '3.9', 'upperLimit': '4.8'}, {'value': '4.6', 'groupId': 'OG001', 'lowerLimit': '4.1', 'upperLimit': '5.1'}, {'value': '4.4', 'groupId': 'OG002', 'lowerLimit': '3.9', 'upperLimit': '4.9'}, {'value': '4.5', 'groupId': 'OG003', 'lowerLimit': '4.1', 'upperLimit': '5.0'}, {'value': '4.7', 'groupId': 'OG004', 'lowerLimit': '4.2', 'upperLimit': '5.2'}]}]}], 'analyses': [{'pValue': '0.85', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'Threshold for statistical significance was 0.05. The plan was to only compare means if the overall test of AVOVA was statistically significant.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Prior to ingestion of study medication to 2 hours after ingestion of the study medication', 'description': 'Pain intensity measured by 11-point Numerical Rating Scale (NRS) of Pain 0 = no pain 10=worst possible pain. Change is calculated as Numerical Rating Scale before medication is administered (denoted as baseline) minus NRS 2- hours past baseline. Higher numbers indicate better outcomes.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Differences between population at 1 hour and 2 hour is due to patients leaving the Emergency Department before 2 hours post-baseline'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Who Received Rescue Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}, {'value': '118', 'groupId': 'OG003'}, {'value': '120', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '400 Ibuprofen/APAP', 'description': '400 mg ibuprofen + 1000 mg acetaminophen\n\n400 ibuprofen/APAP: ibuprofen/acetaminophen 400 mg-1000mg oral tablet'}, {'id': 'OG001', 'title': '800 Ibuprofen/APAP', 'description': '800 mg ibuprofen + 1000 mg acetaminophen\n\n800 ibuprofen/APAP: ibuprofen/acetaminophen 800 mg-1000 mg oral tablet'}, {'id': 'OG002', 'title': 'Codeine/APAP', 'description': '30 mg codeine + 300 mg acetaminophen\n\ncodeine/APAP: Codeine/acetaminophen 30 mg-300mg oral tablet'}, {'id': 'OG003', 'title': 'Hydrocodone/APAP', 'description': '5 mg hydrocodone + 300 mg acetaminophen\n\nhydrocodone/APAP: Hydrocodone/Acetaminophen 5 Mg-300 Mg oral tablet'}, {'id': 'OG004', 'title': 'Oxycodone/APAP', 'description': '5 mg oxycodone + 325 mg acetaminophen\n\noxycodone/APAP: Oxycodone/acetaminophen 5 mg-325 mg oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '28', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.99', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'Threshold for statistical significance = 0.05', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Entire two-hour time period', 'description': 'Number of patients who received additional analgesics divided by total number of patients x 100', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Who Would Choose to Take the Study Medication Again if They Returned to the ED With Similar Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}, {'value': '117', 'groupId': 'OG003'}, {'value': '118', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '400 Ibuprofen/APAP', 'description': '400 mg ibuprofen + 1000 mg acetaminophen\n\n400 ibuprofen/APAP: ibuprofen/acetaminophen 400 mg-1000mg oral tablet'}, {'id': 'OG001', 'title': '800 Ibuprofen/APAP', 'description': '800 mg ibuprofen + 1000 mg acetaminophen\n\n800 ibuprofen/APAP: ibuprofen/acetaminophen 800 mg-1000 mg oral tablet'}, {'id': 'OG002', 'title': 'Codeine/APAP', 'description': '30 mg codeine + 300 mg acetaminophen\n\ncodeine/APAP: Codeine/acetaminophen 30 mg-300mg oral tablet'}, {'id': 'OG003', 'title': 'Hydrocodone/APAP', 'description': '5 mg hydrocodone + 300 mg acetaminophen\n\nhydrocodone/APAP: Hydrocodone/Acetaminophen 5 Mg-300 Mg oral tablet'}, {'id': 'OG004', 'title': 'Oxycodone/APAP', 'description': '5 mg oxycodone + 325 mg acetaminophen\n\noxycodone/APAP: Oxycodone/acetaminophen 5 mg-325 mg oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '89', 'groupId': 'OG003'}, {'value': '81', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'End of two-hour time period', 'description': 'Number of patients who would choose to take study medication again divided by number of patients x 100. Question asked at end of two-hour time period', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Missing data: 1 from codeine/APAP arm, 1 from hydrocodone/APAP arm, 2 from oxycodone/APAP arm'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Who Experience Side Effects Within One Hour of Ingestion of Study Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}, {'value': '119', 'groupId': 'OG003'}, {'value': '120', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '400 Ibuprofen/APAP', 'description': '400 mg ibuprofen + 1000 mg acetaminophen\n\n400 ibuprofen/APAP: ibuprofen/acetaminophen 400 mg-1000mg oral tablet'}, {'id': 'OG001', 'title': '800 Ibuprofen/APAP', 'description': '800 mg ibuprofen + 1000 mg acetaminophen\n\n800 ibuprofen/APAP: ibuprofen/acetaminophen 800 mg-1000 mg oral tablet'}, {'id': 'OG002', 'title': 'Codeine/APAP', 'description': '30 mg codeine + 300 mg acetaminophen\n\ncodeine/APAP: Codeine/acetaminophen 30 mg-300mg oral tablet'}, {'id': 'OG003', 'title': 'Hydrocodone/APAP', 'description': '5 mg hydrocodone + 300 mg acetaminophen\n\nhydrocodone/APAP: Hydrocodone/Acetaminophen 5 Mg-300 Mg oral tablet'}, {'id': 'OG004', 'title': 'Oxycodone/APAP', 'description': '5 mg oxycodone + 325 mg acetaminophen\n\noxycodone/APAP: Oxycodone/acetaminophen 5 mg-325 mg oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.46', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From time of ingestion of study medication to one hour later', 'description': 'Number of patients who experience side effects within one hour ofr ingestion of study medication divided by total number of patients x 100', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Who Experience Side Effects in Two Hours After Ingestion of Study Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}, {'value': '119', 'groupId': 'OG003'}, {'value': '120', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '400 Ibuprofen/APAP', 'description': '400 mg ibuprofen + 1000 mg acetaminophen\n\n400 ibuprofen/APAP: ibuprofen/acetaminophen 400 mg-1000mg oral tablet'}, {'id': 'OG001', 'title': '800 Ibuprofen/APAP', 'description': '800 mg ibuprofen + 1000 mg acetaminophen\n\n800 ibuprofen/APAP: ibuprofen/acetaminophen 800 mg-1000 mg oral tablet'}, {'id': 'OG002', 'title': 'Codeine/APAP', 'description': '30 mg codeine + 300 mg acetaminophen\n\ncodeine/APAP: Codeine/acetaminophen 30 mg-300mg oral tablet'}, {'id': 'OG003', 'title': 'Hydrocodone/APAP', 'description': '5 mg hydrocodone + 300 mg acetaminophen\n\nhydrocodone/APAP: Hydrocodone/Acetaminophen 5 Mg-300 Mg oral tablet'}, {'id': 'OG004', 'title': 'Oxycodone/APAP', 'description': '5 mg oxycodone + 325 mg acetaminophen\n\noxycodone/APAP: Oxycodone/acetaminophen 5 mg-325 mg oral tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.0501', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': '0.05 was the a priori threshold for statistical significance', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From time of ingestion of study medication to two hours later', 'description': 'Number of patients who experience side effects in two hours after ingestion of study medication divided by total number of patients x 100', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Oxycodone/Acetaminophen (APAP)', 'description': '5 mg oxycodone + 325 mg acetaminophen\n\noxycodone/APAP: Oxycodone/acetaminophen 5 mg-325 mg oral tablet'}, {'id': 'FG001', 'title': 'Hydrocodone/APAP', 'description': '5 mg hydrocodone + 300 mg acetaminophen\n\nhydrocodone/APAP: Hydrocodone/Acetaminophen 5 Mg-300 Mg oral tablet'}, {'id': 'FG002', 'title': 'Codeine/APAP', 'description': '30 mg codeine + 300 mg acetaminophen\n\ncodeine/APAP: Codeine/acetaminophen 30 mg-300mg oral tablet'}, {'id': 'FG003', 'title': '400 Ibuprofen/APAP', 'description': '400 mg ibuprofen + 1000 mg acetaminophen\n\n400 ibuprofen/APAP: ibuprofen/acetaminophen 400 mg-1000mg oral tablet'}, {'id': 'FG004', 'title': '800 Ibuprofen/APAP', 'description': '800 mg ibuprofen + 1000 mg acetaminophen\n\n800 ibuprofen/APAP: ibuprofen/acetaminophen 800 mg-1000 mg oral tablet'}], 'periods': [{'title': 'Baseline', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '120'}, {'groupId': 'FG001', 'numSubjects': '120'}, {'groupId': 'FG002', 'numSubjects': '120'}, {'groupId': 'FG003', 'numSubjects': '120'}, {'groupId': 'FG004', 'numSubjects': '120'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '120'}, {'groupId': 'FG001', 'numSubjects': '119'}, {'groupId': 'FG002', 'numSubjects': '120'}, {'groupId': 'FG003', 'numSubjects': '120'}, {'groupId': 'FG004', 'numSubjects': '118'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': "Medication dispensing system malfunction'", 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}]}]}, {'title': '2 Hour Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '120'}, {'groupId': 'FG001', 'numSubjects': '119'}, {'groupId': 'FG002', 'numSubjects': '120'}, {'groupId': 'FG003', 'numSubjects': '120'}, {'groupId': 'FG004', 'numSubjects': '118'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '120'}, {'groupId': 'FG001', 'numSubjects': '118'}, {'groupId': 'FG002', 'numSubjects': '119'}, {'groupId': 'FG003', 'numSubjects': '119'}, {'groupId': 'FG004', 'numSubjects': '116'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Patients were recruited when they came into the ED with a complaint of pain. They were recruited in 2 academic EDs by trained, full-time, bilingual research associates from 11/26/2017 to 11/5/2019'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}, {'value': '120', 'groupId': 'BG003'}, {'value': '118', 'groupId': 'BG004'}, {'value': '597', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Oxycodone/APAP', 'description': '5 mg oxycodone + 325 mg acetaminophen\n\noxycodone/APAP: Oxycodone/acetaminophen 5 mg-325 mg oral tablet'}, {'id': 'BG001', 'title': 'Hydrocodone/APAP', 'description': '5 mg hydrocodone + 300 mg acetaminophen\n\nhydrocodone/APAP: Hydrocodone/Acetaminophen 5 Mg-300 Mg oral tablet'}, {'id': 'BG002', 'title': 'Codeine/APAP', 'description': '30 mg codeine + 300 mg acetaminophen\n\ncodeine/APAP: Codeine/acetaminophen 30 mg-300mg oral tablet'}, {'id': 'BG003', 'title': '400 Ibuprofen/APAP', 'description': '400 mg ibuprofen + 1000 mg acetaminophen\n\n400 ibuprofen/APAP: ibuprofen/acetaminophen 400 mg-1000mg oral tablet'}, {'id': 'BG004', 'title': '800 Ibuprofen/APAP', 'description': '800 mg ibuprofen + 1000 mg acetaminophen\n\n800 ibuprofen/APAP: ibuprofen/acetaminophen 800 mg-1000 mg oral tablet'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36', 'spread': '12', 'groupId': 'BG000'}, {'value': '39', 'spread': '12', 'groupId': 'BG001'}, {'value': '38', 'spread': '12', 'groupId': 'BG002'}, {'value': '36', 'spread': '12', 'groupId': 'BG003'}, {'value': '38', 'spread': '13', 'groupId': 'BG004'}, {'value': '37.4', 'spread': '12', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '50', 'groupId': 'BG004'}, {'value': '265', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}, {'value': '332', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '37', 'groupId': 'BG004'}, {'value': '313', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '87', 'groupId': 'BG003'}, {'value': '81', 'groupId': 'BG004'}, {'value': '281', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '47', 'groupId': 'BG004'}, {'value': '215', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '46', 'groupId': 'BG004'}, {'value': '219', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '147', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '120', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}, {'value': '120', 'groupId': 'BG003'}, {'value': '118', 'groupId': 'BG004'}, {'value': '597', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Initial pain intensity scale', 'classes': [{'categories': [{'title': '0-6', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '15', 'groupId': 'BG005'}]}, {'title': '7', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '50', 'groupId': 'BG005'}]}, {'title': '8', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '99', 'groupId': 'BG005'}]}, {'title': '9', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '95', 'groupId': 'BG005'}]}, {'title': '10', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}, {'value': '70', 'groupId': 'BG003'}, {'value': '69', 'groupId': 'BG004'}, {'value': '338', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Numerical Rating Scale: Scale ranging from 0 "no pain" to 10 "worst imaginable pain" Patients are asked to give number that best represents their pain', 'unitOfMeasure': 'Participants'}, {'title': 'Diagnosis', 'classes': [{'categories': [{'title': 'Sprain or Strain', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}, {'value': '82', 'groupId': 'BG004'}, {'value': '371', 'groupId': 'BG005'}]}, {'title': 'Extremity Fracture', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '87', 'groupId': 'BG005'}]}, {'title': 'Muscle pain', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '66', 'groupId': 'BG005'}]}, {'title': 'Contusion', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '34', 'groupId': 'BG005'}]}, {'title': 'Other', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '39', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Non-Pharmacologic interventions', 'classes': [{'categories': [{'title': '0', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}, {'value': '297', 'groupId': 'BG005'}]}, {'title': 'greater than or equal to 1', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}, {'value': '67', 'groupId': 'BG004'}, {'value': '300', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The 3 patients assigned to treatment arms did not provide any data because of malfunctioning of the medication dispensing system.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-10-16', 'size': 298661, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-10-12T13:43', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'A pharmacist working in an area inaccessible to ED staff will ensure blinding of the study by masking the medication and inserting it into identical unmarked gel capsules, filling any void with small amounts of lactose. Randomization will be performed in blocks of 10 determined by a sequence generated at http://www.randomization.com. The pharmacist will make up numbered research packets based on the random allocation list, each with 5 tablets containing the masked investigational medication. Research packets will be removed sequentially by the nurse from the Pyxis automated medical dispensing system and administered to the study patients in the ED.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2019-11-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-02', 'studyFirstSubmitDate': '2017-05-30', 'resultsFirstSubmitDate': '2021-10-12', 'studyFirstSubmitQcDate': '2017-05-30', 'lastUpdatePostDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-01-02', 'studyFirstPostDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Pain From Before Medication Administered (Baseline) to One-hour Post-baseline', 'timeFrame': 'Prior to Ingestion of study medication to one hour after ingestion of the study medication', 'description': 'Pain intensity measured by 11-point Numerical Rating Scale (NRS) of Pain 0 = no pain 10 = worse possible pain. Change calculated as NRS before medication administered (denoted as baseline) minus NRS 1-hour post-baseline. Higher scores mean more change which is the better outcome.'}], 'secondaryOutcomes': [{'measure': 'Change in Pain From Before Medication Administered (Baseline) to Two Hour Post-baseline', 'timeFrame': 'Prior to ingestion of study medication to 2 hours after ingestion of the study medication', 'description': 'Pain intensity measured by 11-point Numerical Rating Scale (NRS) of Pain 0 = no pain 10=worst possible pain. Change is calculated as Numerical Rating Scale before medication is administered (denoted as baseline) minus NRS 2- hours past baseline. Higher numbers indicate better outcomes.'}, {'measure': 'Percentage of Patients Who Received Rescue Medication', 'timeFrame': 'Entire two-hour time period', 'description': 'Number of patients who received additional analgesics divided by total number of patients x 100'}, {'measure': 'Percentage of Patients Who Would Choose to Take the Study Medication Again if They Returned to the ED With Similar Pain', 'timeFrame': 'End of two-hour time period', 'description': 'Number of patients who would choose to take study medication again divided by number of patients x 100. Question asked at end of two-hour time period'}, {'measure': 'Percentage of Patients Who Experience Side Effects Within One Hour of Ingestion of Study Medication', 'timeFrame': 'From time of ingestion of study medication to one hour later', 'description': 'Number of patients who experience side effects within one hour ofr ingestion of study medication divided by total number of patients x 100'}, {'measure': 'Percentage of Patients Who Experience Side Effects in Two Hours After Ingestion of Study Medication', 'timeFrame': 'From time of ingestion of study medication to two hours later', 'description': 'Number of patients who experience side effects in two hours after ingestion of study medication divided by total number of patients x 100'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acute pain', 'musculoskeletal pain', 'emergency medicine', 'Emergency Service, Hospital', 'analgesics', 'Acetaminophen', 'Ibuprofen', 'oxycodone', 'hydrocodone', 'codeine', 'adult'], 'conditions': ['Musculoskeletal Pain']}, 'referencesModule': {'references': [{'pmid': '33358232', 'type': 'DERIVED', 'citation': 'Bijur PE, Friedman BW, Irizarry E, Chang AK, Gallagher EJ. A Randomized Trial Comparing the Efficacy of Five Oral Analgesics for Treatment of Acute Musculoskeletal Extremity Pain in the Emergency Department. Ann Emerg Med. 2021 Mar;77(3):345-356. doi: 10.1016/j.annemergmed.2020.10.004. Epub 2020 Dec 23.'}]}, 'descriptionModule': {'briefSummary': 'This study compares the efficacy of five oral analgesics: 5 mg oxycodone + 325 mg acetaminophen, 5 mg hydrocodone + 300 mg acetaminophen, 30 mg codeine + 300 mg acetaminophen, 400 mg ibuprofen + 1000 mg acetaminophen, and 800 mg ibuprofen + 1000 mg acetaminophen for the treatment of patients with acute musculoskeletal pain who present to the Emergency Department (ED).', 'detailedDescription': "The optimal treatment of musculoskeletal extremity pain in the ED not known. The study is a randomized controlled trial designed to compare the efficacy of five oral analgesics: 5 mg oxycodone + 325 mg acetaminophen, 5 mg hydrocodone + 300 mg acetaminophen, 30 mg codeine + 300 mg acetaminophen, 400 mg ibuprofen + 1000 mg acetaminophen, and 800 mg ibuprofen + 1000 mg acetaminophen for the treatment of patients with acute musculoskeletal pain. The primary outcome is the between treatment group difference in change in patients' rating of pain intensity one hour after ingestion of the study medication. Secondary outcomes include: 1) the between treatment group difference in change in patients' rating of pain intensity two hours after ingestion of the study medication; 2) difference in proportion of patients who receive rescue medication; 3) difference in proportion of patients who would choose to take the study medication again if they returned to the ED with similar pain; 4) difference in proportion of patients who experience side effects."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients ages 21 through 64 years of age\n* Complaint of acute musculoskeletal pain in one or more extremity, defined as distal to and including the shoulder or hip joints.\n* Pain of less than seven days duration\n* Patient speaks Spanish or English\n* The clinician plans to treat the patient in the ED with oral analgesics and is willing to treat the patient with opioid analgesics or up to 800 mg ibuprofen and 1000 mg acetaminophen\n* Patient is going to receive imaging of the painful extremity\n* Clinician judges patient to have capacity to provide informed consent\n\nExclusion Criteria:\n\n* Patient does not have cell phone or cannot receive a verification phone call on their cell phone while in the ED\n* Any use of methadone currently or previously\n* Chronic condition requiring frequent pain management such as arthritis, sickle cell disease, fibromyalgia, or any neuropathy\n* History of an adverse reaction to any of the study medications\n* Opioids taken in the past 24 hours\n* Ibuprofen or acetaminophen taken in past 24 hours\n* Any other prescribed or over the counter topical or oral analgesics taken in past 24 hrs\n* Pregnancy by either urine or serum human chorionic gonadotropin testing\n* Breastfeeding per patient report\n* History of peptic ulcer disease\n* Medical condition that might affect metabolism of opioid analgesics, acetaminophen, or ibuprofen such as hepatitis, renal insufficiency, hypo- or hyperthyroidism, Addison's, or Cushing's disease\n* Lacerations,\n* Multiple injuries\n* Taking any medicine that might interact with one of the study medications, such as antidepressant SSRI's or tricyclics, antipsychotics, anti-malaria medications quinidine or halofantrine, amiodarone or dronedarone, diphenhydramine, celecoxib, ranitidine, cimetidine, ritonavir, terbinafine, or St John's Wort"}, 'identificationModule': {'nctId': 'NCT03173456', 'briefTitle': 'Comparing Five Oral Analgesics for Treatment of Acute Pain in the Emergency Department (ED)', 'organization': {'class': 'OTHER', 'fullName': 'Albert Einstein College of Medicine'}, 'officialTitle': 'Comparing the Efficacy of Five Oral Analgesics for Treatment of Acute Musculoskeletal Extremity Pain in the Emergency Department', 'orgStudyIdInfo': {'id': '2016-7322'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'oxycodone/acetaminophen (APAP)', 'description': '5 mg oxycodone + 325 mg acetaminophen', 'interventionNames': ['Drug: oxycodone/APAP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'hydrocodone/APAP', 'description': '5 mg hydrocodone + 300 mg acetaminophen', 'interventionNames': ['Drug: hydrocodone/APAP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'codeine/APAP', 'description': '30 mg codeine + 300 mg acetaminophen', 'interventionNames': ['Drug: codeine/APAP']}, {'type': 'ACTIVE_COMPARATOR', 'label': '400 ibuprofen/APAP', 'description': '400 mg ibuprofen + 1000 mg acetaminophen', 'interventionNames': ['Drug: 400 ibuprofen/APAP']}, {'type': 'ACTIVE_COMPARATOR', 'label': '800 ibuprofen/APAP', 'description': '800 mg ibuprofen + 1000 mg acetaminophen', 'interventionNames': ['Drug: 800 ibuprofen/APAP']}], 'interventions': [{'name': 'oxycodone/APAP', 'type': 'DRUG', 'otherNames': ['Percocet'], 'description': 'Oxycodone/acetaminophen 5 mg-325 mg oral tablet', 'armGroupLabels': ['oxycodone/acetaminophen (APAP)']}, {'name': 'hydrocodone/APAP', 'type': 'DRUG', 'otherNames': ['Vicodin'], 'description': 'Hydrocodone/Acetaminophen 5 Mg-300 Mg oral tablet', 'armGroupLabels': ['hydrocodone/APAP']}, {'name': 'codeine/APAP', 'type': 'DRUG', 'otherNames': ['Tylenol # 3'], 'description': 'Codeine/acetaminophen 30 mg-300mg oral tablet', 'armGroupLabels': ['codeine/APAP']}, {'name': '400 ibuprofen/APAP', 'type': 'DRUG', 'otherNames': ['Motrin, Tylenol'], 'description': 'ibuprofen/acetaminophen 400 mg-1000mg oral tablet', 'armGroupLabels': ['400 ibuprofen/APAP']}, {'name': '800 ibuprofen/APAP', 'type': 'DRUG', 'otherNames': ['Motrin, Tylenol'], 'description': 'ibuprofen/acetaminophen 800 mg-1000 mg oral tablet', 'armGroupLabels': ['800 ibuprofen/APAP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'Benjamin Friedman, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Albert Einstein College of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Albert Einstein College of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Emergency Medicine', 'investigatorFullName': 'Polly Bijur', 'investigatorAffiliation': 'Albert Einstein College of Medicine'}}}}