Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2026-04-02 @ 6:57 AM
Study NCT ID:
NCT00654069
Status:
COMPLETED
Last Update Posted:
2018-08-22
First Post:
2008-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety/Efficacy Study of Oxycodone HCl/Niacin to Treat Pain After Bunionectomy
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': 'D010098', 'term': 'Oxycodone'}, {'id': 'D009525', 'term': 'Niacin'}], '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': 'D009539', 'term': 'Nicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rspivey@acurapharm.com', 'phone': '847-705-7709', 'title': 'Dr. Ron Spivey', 'organization': 'Acura Pharma'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '48 hours', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo Pill', 'otherNumAtRisk': 136, 'deathsNumAtRisk': 136, 'otherNumAffected': 51, 'seriousNumAtRisk': 136, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Acurox 5/30', 'description': 'oxycodone 5mg/niacin 30mg', 'otherNumAtRisk': 135, 'deathsNumAtRisk': 135, 'otherNumAffected': 104, 'seriousNumAtRisk': 135, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Acurox 7.5/30', 'description': 'oxycodone 7.5mg/niacin 30mg', 'otherNumAtRisk': 134, 'deathsNumAtRisk': 134, 'otherNumAffected': 117, 'seriousNumAtRisk': 134, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 68, 'numAffected': 68}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 83, 'numAffected': 83}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 46, 'numAffected': 46}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 67, 'numAffected': 67}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 32, 'numAffected': 32}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Pruritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 135, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'SPID48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo Tablet'}, {'id': 'OG001', 'title': 'Acurox 5/30', 'description': 'oxycodone 5mg/niacin 30mg'}, {'id': 'OG002', 'title': 'Acurox 7.5/30', 'description': 'oxycodone 7.5mg/niacin 30mg'}], 'classes': [{'categories': [{'measurements': [{'value': '604.48', 'spread': '1124.857', 'groupId': 'OG000'}, {'value': '998.46', 'spread': '1102.164', 'groupId': 'OG001'}, {'value': '1224.97', 'spread': '1128.569', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours', 'description': 'Time weighted Sum of Pain Intensity Differences over the first 48 hours (SPID48) is the sum of the Pain Intensity Difference (PID) scores observed at 0.5 , 1, 2, 3, 4, 5, 6, 12, 18, 24, 30, 36, 42, and 48 hours post-dose. Pain Intensity scores at each timepoint are based on a 100 mm visual analog scale (VAS) from 0 = no pain to 100 = worst pain imaginable. PID is calculated as the timepoint score less the baseline pre-dose score (i.e. PID.5 = PI.5 - PI0).\n\nSPID48 = the PID for each timepoint multiplied by a time weighting factor; which is the difference (in hours) between the PID observation and prior observation. SPID48 = PID.5\\*.5 + PID1\\*.5 + PID2\\*1 + PID3\\*1 + PID4\\*1 + PID6\\*2 +PID12\\*6 + PID18\\*6 +PID24\\*6 + PID30\\*6 + PID36\\*6 + PID42\\*6 + PID48\\*6. The maximum SPID48 value is 4,800 (assumes PI0 of 100 and a PI of 0 at all subsequent timepoints) with a midpoint SPID48 of 2,400 (PI0=50 and PI of 0 at all subsequent readings).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': '2 Tablets Every 6 Hours'}, {'id': 'FG001', 'title': 'Acurox 5/30mg', 'description': '2x oxycodone 5mg/naicin 30mg every 6 hours'}, {'id': 'FG002', 'title': 'Acurox 7.5/30mg', 'description': '2x oxycodone 7.5mg/naicin 30mg every 6 hours'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '136'}, {'groupId': 'FG001', 'numSubjects': '135'}, {'groupId': 'FG002', 'numSubjects': '134'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '119'}, {'groupId': 'FG001', 'numSubjects': '124'}, {'groupId': 'FG002', 'numSubjects': '116'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '18'}]}]}], 'recruitmentDetails': '405 post-bunionectomy patients', 'preAssignmentDetails': 'Subjects dose immediately post-surgery when pain intensity was equal to or greater than moderate. Dosed and followed for 48 hours.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'BG000'}, {'value': '135', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}, {'value': '405', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': '2x Placebo Tablets'}, {'id': 'BG001', 'title': 'Acurox 5/30', 'description': '2x oxycodone/niacin 5/30mg tablets'}, {'id': 'BG002', 'title': 'Acurox 7.5/30', 'description': '2x oxycodone/niacin 7.5/30mg tablets'}, {'id': 'BG003', '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'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}, {'value': '350', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.0', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '71'}, {'value': '41.8', 'groupId': 'BG001', 'lowerLimit': '18', 'upperLimit': '76'}, {'value': '41.6', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '77'}, {'value': '41.8', 'groupId': 'BG003', 'lowerLimit': '18', 'upperLimit': '77'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}, {'value': '359', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '136', 'groupId': 'BG000'}, {'value': '135', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}, {'value': '405', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 405}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-21', 'studyFirstSubmitDate': '2008-04-02', 'resultsFirstSubmitDate': '2018-06-27', 'studyFirstSubmitQcDate': '2008-04-02', 'lastUpdatePostDateStruct': {'date': '2018-08-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-21', 'studyFirstPostDateStruct': {'date': '2008-04-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SPID48', 'timeFrame': '48 hours', 'description': 'Time weighted Sum of Pain Intensity Differences over the first 48 hours (SPID48) is the sum of the Pain Intensity Difference (PID) scores observed at 0.5 , 1, 2, 3, 4, 5, 6, 12, 18, 24, 30, 36, 42, and 48 hours post-dose. Pain Intensity scores at each timepoint are based on a 100 mm visual analog scale (VAS) from 0 = no pain to 100 = worst pain imaginable. PID is calculated as the timepoint score less the baseline pre-dose score (i.e. PID.5 = PI.5 - PI0).\n\nSPID48 = the PID for each timepoint multiplied by a time weighting factor; which is the difference (in hours) between the PID observation and prior observation. SPID48 = PID.5\\*.5 + PID1\\*.5 + PID2\\*1 + PID3\\*1 + PID4\\*1 + PID6\\*2 +PID12\\*6 + PID18\\*6 +PID24\\*6 + PID30\\*6 + PID36\\*6 + PID42\\*6 + PID48\\*6. The maximum SPID48 value is 4,800 (assumes PI0 of 100 and a PI of 0 at all subsequent timepoints) with a midpoint SPID48 of 2,400 (PI0=50 and PI of 0 at all subsequent readings).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pain'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '21231862', 'type': 'DERIVED', 'citation': 'Daniels SE, Spivey RJ, Singla S, Golf M, Clark FJ. Efficacy and safety of oxycodone HCl/niacin tablets for the treatment of moderate-to-severe postoperative pain following bunionectomy surgery. Curr Med Res Opin. 2011 Mar;27(3):593-603. doi: 10.1185/03007995.2010.548291. Epub 2011 Jan 13.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether oxycodone HCl and niacin are effective in the treatment of pain following bunionectomy surgery.', 'detailedDescription': 'This was a Phase III, randomized, double blind, placebo controlled, multicenter, repeat dose study of the safety and efficacy of 2 dose levels of Acurox™ Tablets versus placebo for the treatment of moderate to severe postoperative pain following bunionectomy surgery.\n\nPatients underwent a primary unilateral first metatarsal bunionectomy with or without ipsilateral hammer toe repair during standardized local anesthesia with intravenous (IV) sedation. Eligible patients who reported moderate or severe pain within 6 hours after surgery entered the Treatment Phase and were randomized to 1 of 3 double blind treatments: placebo tablets or 1 of 2 dose levels of Acurox™ Tablets (ocyxcodone HCl/niacin). The Treatment Phase continued with study medication every 6 hours (irrespective of rescue medication use) for 48 hours (8 doses of study medication). Toradol (ketorolac tromethamine) was available as a rescue medication upon request.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient is male or female at least 18 years of age\n* For women of child-bearing potential: woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control\n* Patient is scheduled to have a bunionectomy\n* Patient must be willing to stay at the study site for at least 48 hours from the initial dose of study medication post-surgery\n\nExclusion Criteria:\n\n* Patient has a current disease or history of a disease that will impact the study or the patient's well-being\n* Patient has used or intends to use any of the medications that are prohibited by the protocol\n* Patient has a history of drug or alcohol abuse or dependence, or patient has a positive urine drug screen\n* Patient is hypersensitive to any of the medications to be used in the study\n* Patient has taken another investigational drug within 30 days prior to Screening"}, 'identificationModule': {'nctId': 'NCT00654069', 'briefTitle': 'Safety/Efficacy Study of Oxycodone HCl/Niacin to Treat Pain After Bunionectomy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Acura Pharmaceuticals Inc.'}, 'officialTitle': 'A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter, Repeat-dose Study of the Safety and Efficacy of Acuroc Tablets Following Bunionectomy Surgery in Adult Patients', 'orgStudyIdInfo': {'id': 'AP-ADF-105'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Tablet', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Acurox 5/30mg', 'description': 'Oxycodone HCl 5mg/Niacin 30mg tablet', 'interventionNames': ['Drug: Acurox 5/30 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Acurox 7.5/30', 'description': 'Oxycodone HCl 7.5mg/Niacin 30mg tablet', 'interventionNames': ['Drug: Acurox 7.5/30']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Placebo Tablet'], 'description': '2 tablets every 6 hours for 48 hours', 'armGroupLabels': ['Placebo']}, {'name': 'Acurox 5/30 mg', 'type': 'DRUG', 'otherNames': ['oxycodone/niacin 5/30mg'], 'description': '2 tablets every 6 hours for 48 hours', 'armGroupLabels': ['Acurox 5/30mg']}, {'name': 'Acurox 7.5/30', 'type': 'DRUG', 'otherNames': ['oxycodone/niacin 7.5/30mg'], 'description': '2 tablets every 6 hours for 48 hours', 'armGroupLabels': ['Acurox 7.5/30']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Acura Pharmaceuticals Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}