Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-26 @ 4:16 PM
Study NCT ID:
NCT05544734
Status:
COMPLETED
Last Update Posted:
2023-09-28
First Post:
2022-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Hydrocodone Compared to Acetaminophen and Ibuprofen for Post-nail Procedure Analgesia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009260', 'term': 'Nail Diseases'}, {'id': 'D009264', 'term': 'Nails, Malformed'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006853', 'term': 'Hydrocodone'}, {'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'C083640', 'term': 'acetaminophen, hydrocodone drug combination'}, {'id': 'C514822', 'term': 'oxycodone-acetaminophen'}, {'id': 'D007052', 'term': 'Ibuprofen'}], 'ancestors': [{'id': 'D003061', 'term': 'Codeine'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'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': 'shl9032@med.cornell.edu', 'phone': '6469623376', 'title': 'Dr Shari Lipner', 'organization': 'Weill Cornell Medicine'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '30 days', 'eventGroups': [{'id': 'EG000', 'title': 'Hydrocodone 5mg/Acetaminophen 325mg', 'description': 'Participants receive oral hydrocodone 5 mg/acetaminophen 325 mg every 4 hours for 2 days, followed by oral acetaminophen 1000 mg and oral ibuprofen 400 mg every 6 hours for 4 days\n\nHydrocodone 5Mg/Acetaminophen 325Mg Tab: 5 mg/325 mg tablet\n\nAcetaminophen 1000mg: 1000 mg tablet\n\nIbuprofen 400 mg: 400 mg tablet', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Acetaminophen 1000mg + Ibuprofen 400mg', 'description': 'Participants receive oral acetaminophen 1000 mg and oral ibuprofen 400 mg every 6 hours for 6 days\n\nAcetaminophen 1000mg: 1000 mg tablet\n\nIbuprofen 400 mg: 400 mg tablet', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Pain Scores on Postoperative Day 2, as Measured by the Wong-Baker 0-to-10 Pain Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hydrocodone 5mg/Acetaminophen 325mg', 'description': 'Participants receive oral hydrocodone 5 mg/acetaminophen 325 mg every 4 hours for 2 days, followed by oral acetaminophen 1000 mg and oral ibuprofen 400 mg every 6 hours for 4 days\n\nHydrocodone 5Mg/Acetaminophen 325Mg Tab: 5 mg/325 mg tablet\n\nAcetaminophen 1000mg: 1000 mg tablet\n\nIbuprofen 400 mg: 400 mg tablet'}, {'id': 'OG001', 'title': 'Acetaminophen 1000mg + Ibuprofen 400mg', 'description': 'Participants receive oral acetaminophen 1000 mg and oral ibuprofen 400 mg every 6 hours for 6 days\n\nAcetaminophen 1000mg: 1000 mg tablet\n\nIbuprofen 400 mg: 400 mg tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '1.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.69', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.30', 'ciLowerLimit': '-1.85', 'ciUpperLimit': '1.25', 'estimateComment': 'Direction = Hydrocodone group mean change (i.e., change = baseline to postoperative day 2) minus Non-Hydrocodone group mean change (i.e., change = baseline to postoperative day 2).', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 2 days', 'description': 'Change in pain scores obtained with the Wong-Baker 0-to-10 pain scale between the 2 groups on postoperative day 2. The Wong-Baker 0-to-10 pain scale is used for rating the severity of pain, with scores ranging from 0 to 10, and higher scores indicating greater severity of pain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Health-related Quality of Life Scores on Postoperative Days 3 and 6, as Measured by an Adapted APS-POQ-R Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hydrocodone 5mg/Acetaminophen 325mg', 'description': 'Participants receive oral hydrocodone 5 mg/acetaminophen 325 mg every 4 hours for 2 days, followed by oral acetaminophen 1000 mg and oral ibuprofen 400 mg every 6 hours for 4 days\n\nHydrocodone 5Mg/Acetaminophen 325Mg Tab: 5 mg/325 mg tablet\n\nAcetaminophen 1000mg: 1000 mg tablet\n\nIbuprofen 400 mg: 400 mg tablet'}, {'id': 'OG001', 'title': 'Acetaminophen 1000mg + Ibuprofen 400mg', 'description': 'Participants receive oral acetaminophen 1000 mg and oral ibuprofen 400 mg every 6 hours for 6 days\n\nAcetaminophen 1000mg: 1000 mg tablet\n\nIbuprofen 400 mg: 400 mg tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '12.7', 'spread': '11.2', 'groupId': 'OG000'}, {'value': '10.4', 'spread': '9.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.62', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.30', 'ciLowerLimit': '-7.25', 'ciUpperLimit': '11.85', 'estimateComment': 'Direction = Hydrocodone group mean change (i.e., change = postoperative day 3 to postoperative day 6) minus Non-Hydrocodone group mean change (i.e., change = postoperative day 3 to postoperative day 6).', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '3 days, 6 days (end of study)', 'description': 'Change in health-related quality of life associated with pain obtained with an adapted version of the APS-POQ-R (APS Patient Outcome Questionnaire) between the 2 groups on postoperative days 3 and 6. The APS-POQ-R is a questionnaire used for rating health-related quality of life associated with pain, with scores of each domain ranging from 0 to 10 or 0% to 100%, and higher scores indicating greater severity of impact on quality of life (12 domains summed up for total score range of minimum 0 to maximum 120).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Hydrocodone 5mg/Acetaminophen 325mg', 'description': 'Participants receive oral hydrocodone 5 mg/acetaminophen 325 mg every 4 hours for 2 days, followed by oral acetaminophen 1000 mg and oral ibuprofen 400 mg every 6 hours for 4 days\n\nHydrocodone 5Mg/Acetaminophen 325Mg Tab: 5 mg/325 mg tablet\n\nAcetaminophen 1000mg: 1000 mg tablet\n\nIbuprofen 400 mg: 400 mg tablet'}, {'id': 'FG001', 'title': 'Acetaminophen 1000mg + Ibuprofen 400mg', 'description': 'Participants receive oral acetaminophen 1000 mg and oral ibuprofen 400 mg every 6 hours for 6 days\n\nAcetaminophen 1000mg: 1000 mg tablet\n\nIbuprofen 400 mg: 400 mg tablet'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Hydrocodone 5mg/Acetaminophen 325mg', 'description': 'Participants receive oral hydrocodone 5 mg/acetaminophen 325 mg every 4 hours for 2 days, followed by oral acetaminophen 1000 mg and oral ibuprofen 400 mg every 6 hours for 4 days\n\nHydrocodone 5Mg/Acetaminophen 325Mg Tab: 5 mg/325 mg tablet\n\nAcetaminophen 1000mg: 1000 mg tablet\n\nIbuprofen 400 mg: 400 mg tablet'}, {'id': 'BG001', 'title': 'Acetaminophen 1000mg + Ibuprofen 400mg', 'description': 'Participants receive oral acetaminophen 1000 mg and oral ibuprofen 400 mg every 6 hours for 6 days\n\nAcetaminophen 1000mg: 1000 mg tablet\n\nIbuprofen 400 mg: 400 mg tablet'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.3', 'groupId': 'BG000', 'lowerLimit': '22', 'upperLimit': '84'}, {'value': '47.7', 'groupId': 'BG001', 'lowerLimit': '23', 'upperLimit': '69'}, {'value': '50.5', 'groupId': 'BG002', 'lowerLimit': '22', 'upperLimit': '84'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-08-15', 'size': 1780149, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-08-22T14:54', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-25', 'studyFirstSubmitDate': '2022-09-13', 'resultsFirstSubmitDate': '2023-08-29', 'studyFirstSubmitQcDate': '2022-09-13', 'lastUpdatePostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-25', 'studyFirstPostDateStruct': {'date': '2022-09-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Pain Scores on Postoperative Day 2, as Measured by the Wong-Baker 0-to-10 Pain Scale', 'timeFrame': 'Baseline, 2 days', 'description': 'Change in pain scores obtained with the Wong-Baker 0-to-10 pain scale between the 2 groups on postoperative day 2. The Wong-Baker 0-to-10 pain scale is used for rating the severity of pain, with scores ranging from 0 to 10, and higher scores indicating greater severity of pain.'}], 'secondaryOutcomes': [{'measure': 'Change in Health-related Quality of Life Scores on Postoperative Days 3 and 6, as Measured by an Adapted APS-POQ-R Questionnaire', 'timeFrame': '3 days, 6 days (end of study)', 'description': 'Change in health-related quality of life associated with pain obtained with an adapted version of the APS-POQ-R (APS Patient Outcome Questionnaire) between the 2 groups on postoperative days 3 and 6. The APS-POQ-R is a questionnaire used for rating health-related quality of life associated with pain, with scores of each domain ranging from 0 to 10 or 0% to 100%, and higher scores indicating greater severity of impact on quality of life (12 domains summed up for total score range of minimum 0 to maximum 120).'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nail diseases', 'nail biopsy', 'nail procedure', 'pain management'], 'conditions': ['Nail Diseases', 'Nail Abnormality']}, 'referencesModule': {'references': [{'pmid': '37619705', 'type': 'DERIVED', 'citation': 'Hwang JK, Ricardo JW, Lipner SR. Combination of acetaminophen and ibuprofen is noninferior to acetaminophen and hydrocodone for postnail procedure analgesia: A randomized controlled trial. J Am Acad Dermatol. 2023 Dec;89(6):1300-1302. doi: 10.1016/j.jaad.2023.08.042. Epub 2023 Aug 22. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety and efficacy of ropivacaine and hydrocodone for nail-procedure associated pain management. The investigators hypothesize that ropivacaine with hydrocodone will be superior to ropivacaine with acetaminophen and ibuprofen for managing pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing fingernail or toenail, excision, or shave biopsy\n* Must understand and voluntarily sign an informed consent form\n* Must be male or female and aged 18-95 years at time of consent\n* Must be able to adhere to the study visit schedule and other protocol requirements\n\nExclusion Criteria:\n\n* Subject is unable to provide written informed consent for any reason\n* Subject has peripheral vascular disease, arterial insufficiency, peripheral neuropathy\n* Subject is on Aspirin, NSAIDs, or consumes a chronic medication for control of any other chronic pain\n* Subject has a history of opioid or alcohol use disorder\n* Subject has a history of peptic ulcer disease, gastritis, chronic renal insufficiency or a history of kidney disease, or has underlying liver disease\n* Subject has a history of severe constipation\n* Subject is sensitive or allergic to any of the elements included in this study\n* Subject is unable to complete the required pain dairy\n* Subject is pregnant, planning pregnancy, or nursing'}, 'identificationModule': {'nctId': 'NCT05544734', 'briefTitle': 'Hydrocodone Compared to Acetaminophen and Ibuprofen for Post-nail Procedure Analgesia', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'Analysis of Hydrocodone Compared to Acetaminophen and Ibuprofen for Post-nail Procedure Analgesia', 'orgStudyIdInfo': {'id': '21-10024054'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hydrocodone 5mg/acetaminophen 325mg', 'description': 'Participants receive oral hydrocodone 5 mg/acetaminophen 325 mg every 4 hours for 2 days, followed by oral acetaminophen 1000 mg and oral ibuprofen 400 mg every 6 hours for 4 days', 'interventionNames': ['Drug: Hydrocodone 5Mg/Acetaminophen 325Mg Tab', 'Drug: Acetaminophen 1000mg', 'Drug: Ibuprofen 400 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Acetaminophen 1000mg + Ibuprofen 400mg', 'description': 'Participants receive oral acetaminophen 1000 mg and oral ibuprofen 400 mg every 6 hours for 6 days', 'interventionNames': ['Drug: Acetaminophen 1000mg', 'Drug: Ibuprofen 400 mg']}], 'interventions': [{'name': 'Hydrocodone 5Mg/Acetaminophen 325Mg Tab', 'type': 'DRUG', 'otherNames': ['Vicodin', 'Norco', 'Lortab'], 'description': '5 mg/325 mg tablet', 'armGroupLabels': ['Hydrocodone 5mg/acetaminophen 325mg']}, {'name': 'Acetaminophen 1000mg', 'type': 'DRUG', 'otherNames': ['Tylenol'], 'description': '1000 mg tablet', 'armGroupLabels': ['Acetaminophen 1000mg + Ibuprofen 400mg', 'Hydrocodone 5mg/acetaminophen 325mg']}, {'name': 'Ibuprofen 400 mg', 'type': 'DRUG', 'otherNames': ['Advil', 'Motrin'], 'description': '400 mg tablet', 'armGroupLabels': ['Acetaminophen 1000mg + Ibuprofen 400mg', 'Hydrocodone 5mg/acetaminophen 325mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Medical College of Cornell University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Shari Lipner, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College of Cornell University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}