Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2026-03-03 @ 12:42 AM
Study NCT ID:
NCT02455518
Status:
COMPLETED
Last Update Posted:
2018-02-13
First Post:
2015-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparative Efficacy of 4 Oral Analgesics
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C514822', 'term': 'oxycodone-acetaminophen'}, {'id': 'C526278', 'term': 'acetaminophen, codeine drug combination'}, {'id': 'D007052', 'term': 'Ibuprofen'}, {'id': 'D000082', 'term': 'Acetaminophen'}], 'ancestors': [{'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'achang3@yahoo.com', 'phone': '2125555555', 'title': 'Dr. Andrew Chang', 'organization': 'Albany Medical College'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were not collected', 'eventGroups': [{'id': 'EG000', 'title': 'Oxycodone/Acetaminophen', 'description': 'Oxycodone/acetaminophen (5 mg/325 mg)\n\nOxycodone/acetaminophen', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Hydrocodone/Acetaminophen', 'description': 'Hydrocodone/acetaminophen (5 mg/300 mg)\n\nHydrocodone/acetaminophen', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Codeine/Acetaminophen', 'description': 'Codeine/acetaminophen (30 mg/300 mg)\n\nCodeine/acetaminophen', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Ibuprofen/Acetaminophen', 'description': 'Ibuprofen/acetaminophen (400 mg/1000 mg)\n\nIbuprofen/acetaminophen', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '101', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxycodone/Acetaminophen', 'description': 'Oxycodone/acetaminophen (5 mg/325 mg)\n\nOxycodone/acetaminophen'}, {'id': 'OG001', 'title': 'Hydrocodone/Acetaminophen', 'description': 'Hydrocodone/acetaminophen (5 mg/300 mg)\n\nHydrocodone/acetaminophen'}, {'id': 'OG002', 'title': 'Codeine/Acetaminophen', 'description': 'Codeine/acetaminophen (30 mg/300 mg)\n\nCodeine/acetaminophen'}, {'id': 'OG003', 'title': 'Ibuprofen/Acetaminophen', 'description': 'Ibuprofen/acetaminophen (400 mg/1000 mg)\n\nIbuprofen/acetaminophen'}], 'classes': [{'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000', 'lowerLimit': '3.7', 'upperLimit': '5.0'}, {'value': '3.5', 'groupId': 'OG001', 'lowerLimit': '2.9', 'upperLimit': '4.2'}, {'value': '3.9', 'groupId': 'OG002', 'lowerLimit': '3.2', 'upperLimit': '4.5'}, {'value': '4.3', 'groupId': 'OG003', 'lowerLimit': '3.6', 'upperLimit': '4.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 hours', 'description': 'Change in numerical rating scale (NRS) pre and 2 hours post receiving study medication while in the ED. The NRS is a validated 11-point numerical scale that ranges from 0 (no pain) to 10 (worst pain possible)', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '101', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxycodone/Acetaminophen', 'description': 'Oxycodone/acetaminophen (5 mg/325 mg)\n\nOxycodone/acetaminophen'}, {'id': 'OG001', 'title': 'Hydrocodone/Acetaminophen', 'description': 'Hydrocodone/acetaminophen (5 mg/300 mg)\n\nHydrocodone/acetaminophen'}, {'id': 'OG002', 'title': 'Codeine/Acetaminophen', 'description': 'Codeine/acetaminophen (30 mg/300 mg)\n\nCodeine/acetaminophen'}, {'id': 'OG003', 'title': 'Ibuprofen/Acetaminophen', 'description': 'Ibuprofen/acetaminophen (400 mg/1000 mg)\n\nIbuprofen/acetaminophen'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000', 'lowerLimit': '2.6', 'upperLimit': '3.7'}, {'value': '2.4', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '3.0'}, {'value': '2.7', 'groupId': 'OG002', 'lowerLimit': '2.1', 'upperLimit': '3.3'}, {'value': '2.9', 'groupId': 'OG003', 'lowerLimit': '2.4', 'upperLimit': '3.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 hour', 'description': 'Change in numerical rating scale (NRS) pre and 1-hour post receiving study medication while in the ED. The NRS is a validated 11-point numerical scale that ranges from 0 (no pain) to 10 (worst pain possible)', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Oxycodone/Acetaminophen', 'description': 'Oxycodone/acetaminophen (5 mg/325 mg)\n\nOxycodone/acetaminophen'}, {'id': 'FG001', 'title': 'Hydrocodone/Acetaminophen', 'description': 'Hydrocodone/acetaminophen (5 mg/300 mg)\n\nHydrocodone/acetaminophen'}, {'id': 'FG002', 'title': 'Codeine/Acetaminophen', 'description': 'Codeine/acetaminophen (30 mg/300 mg)\n\nCodeine/acetaminophen'}, {'id': 'FG003', 'title': 'Ibuprofen/Acetaminophen', 'description': 'Ibuprofen/acetaminophen (400 mg/1000 mg)\n\nIbuprofen/acetaminophen'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '104'}, {'groupId': 'FG001', 'numSubjects': '104'}, {'groupId': 'FG002', 'numSubjects': '104'}, {'groupId': 'FG003', 'numSubjects': '104'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '104'}, {'groupId': 'FG001', 'numSubjects': '103'}, {'groupId': 'FG002', 'numSubjects': '103'}, {'groupId': 'FG003', 'numSubjects': '101'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}, {'value': '101', 'groupId': 'BG003'}, {'value': '411', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Oxycodone/Acetaminophen', 'description': 'Oxycodone/acetaminophen (5 mg/325 mg)\n\nOxycodone/acetaminophen'}, {'id': 'BG001', 'title': 'Hydrocodone/Acetaminophen', 'description': 'Hydrocodone/acetaminophen (5 mg/300 mg)\n\nHydrocodone/acetaminophen'}, {'id': 'BG002', 'title': 'Codeine/Acetaminophen', 'description': 'Codeine/acetaminophen (30 mg/300 mg)\n\nCodeine/acetaminophen'}, {'id': 'BG003', 'title': 'Ibuprofen/Acetaminophen', 'description': 'Ibuprofen/acetaminophen (400 mg/1000 mg)\n\nIbuprofen/acetaminophen'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37', 'spread': '12', 'groupId': 'BG000'}, {'value': '37', 'spread': '13', 'groupId': 'BG001'}, {'value': '37', 'spread': '12', 'groupId': 'BG002'}, {'value': '37', 'spread': '11', 'groupId': 'BG003'}, {'value': '37', 'spread': '12', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}, {'value': '199', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}, {'value': '212', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Latino', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}, {'value': '247', 'groupId': 'BG004'}]}]}, {'title': 'African-American', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '122', 'groupId': 'BG004'}]}]}, {'title': 'Caucasian', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}]}]}, {'title': 'East Asian/Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}, {'value': '101', 'groupId': 'BG003'}, {'value': '411', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-05-27', 'size': 185470, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-02-07T19:53', 'hasProtocol': True}, {'date': '2015-05-27', 'size': 225863, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2018-02-07T19:55', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 416}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2017-10-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-07', 'studyFirstSubmitDate': '2015-05-22', 'resultsFirstSubmitDate': '2017-12-14', 'studyFirstSubmitQcDate': '2015-05-26', 'lastUpdatePostDateStruct': {'date': '2018-02-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-02-07', 'studyFirstPostDateStruct': {'date': '2015-05-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores', 'timeFrame': '2 hours', 'description': 'Change in numerical rating scale (NRS) pre and 2 hours post receiving study medication while in the ED. The NRS is a validated 11-point numerical scale that ranges from 0 (no pain) to 10 (worst pain possible)'}], 'secondaryOutcomes': [{'measure': 'Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores', 'timeFrame': '1 hour', 'description': 'Change in numerical rating scale (NRS) pre and 1-hour post receiving study medication while in the ED. The NRS is a validated 11-point numerical scale that ranges from 0 (no pain) to 10 (worst pain possible)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pain'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '29114833', 'type': 'DERIVED', 'citation': 'Chang AK, Bijur PE, Esses D, Barnaby DP, Baer J. Effect of a Single Dose of Oral Opioid and Nonopioid Analgesics on Acute Extremity Pain in the Emergency Department: A Randomized Clinical Trial. JAMA. 2017 Nov 7;318(17):1661-1667. doi: 10.1001/jama.2017.16190.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to perform a randomized, double blind 4-arm clinical trial of the comparative efficacy of 4 oral analgesics in the initial management of acute musculoskeletal extremity pain presenting to the ED.', 'detailedDescription': 'To perform a randomized, double blind 4-arm clinical trial of the comparative efficacy of 4 oral analgesics in the initial management of acute musculoskeletal extremity pain presenting to the ED. The 4 groups are as follows:\n\n1. Oxycodone/acetaminophen (5/325)\n2. Hydrocodone/acetaminophen (5/325)\n3. Codeine/acetaminophen (30/300)\n4. Ibuprofen/acetaminophen (400/1000)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Complaint of acute pain of \\< 7 days duration\n* Location of pain in one or more extremities defined as distal to and including the shoulder joint in the upper extremities and distal to and including the hip joint in the lower extremities;\n* Radiologic evaluation is planned\n\nExclusion Criteria:\n\n* Inability to confirm reliable means of phone followup.\n* Past use of methadone\n* Chronic condition requiring frequent pain management such as 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 8 hours\n* Pregnancy by either urine or serum HCG testing\n* Breastfeeding per patient report\n* History of peptic ulcer disease\n* Report of any prior use of recreational narcotics\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* 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, ritanovir, terbinafine, or St John's Wort."}, 'identificationModule': {'nctId': 'NCT02455518', 'briefTitle': 'Comparative Efficacy of 4 Oral Analgesics', 'organization': {'class': 'OTHER', 'fullName': 'Montefiore Medical Center'}, 'officialTitle': 'Comparative Efficacy of 4 Oral Analgesics for the Initial Management of Acute Musculoskeletal Extremity Pain', 'orgStudyIdInfo': {'id': '2014-4156'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Oxycodone/acetaminophen', 'description': 'Oxycodone/acetaminophen (5 mg/325 mg)', 'interventionNames': ['Drug: Oxycodone/acetaminophen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hydrocodone/acetaminophen', 'description': 'Hydrocodone/acetaminophen (5 mg/300 mg)', 'interventionNames': ['Drug: Hydrocodone/acetaminophen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Codeine/acetaminophen', 'description': 'Codeine/acetaminophen (30 mg/300 mg)', 'interventionNames': ['Drug: Codeine/acetaminophen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ibuprofen/acetaminophen', 'description': 'Ibuprofen/acetaminophen (400 mg/1000 mg)', 'interventionNames': ['Drug: Ibuprofen/acetaminophen']}], 'interventions': [{'name': 'Oxycodone/acetaminophen', 'type': 'DRUG', 'otherNames': ['Percocet'], 'armGroupLabels': ['Oxycodone/acetaminophen']}, {'name': 'Hydrocodone/acetaminophen', 'type': 'DRUG', 'otherNames': ['Norco'], 'armGroupLabels': ['Hydrocodone/acetaminophen']}, {'name': 'Codeine/acetaminophen', 'type': 'DRUG', 'otherNames': ['Tylenol with codeine'], 'armGroupLabels': ['Codeine/acetaminophen']}, {'name': 'Ibuprofen/acetaminophen', 'type': 'DRUG', 'armGroupLabels': ['Ibuprofen/acetaminophen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montefiore Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Andrew Chang, MD', 'investigatorAffiliation': 'Montefiore Medical Center'}}}}