Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-25 @ 4:47 PM
Study NCT ID:
NCT01270659
Status:
COMPLETED
Last Update Posted:
2017-06-20
First Post:
2011-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy Study of Fentanyl Buccal Tablet Use in the Emergency Department for Isolated Extremity Injury
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': 'D005283', 'term': 'Fentanyl'}, {'id': 'C514822', 'term': 'oxycodone-acetaminophen'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Nasir-Mushtaq@ouhsc.edu', 'phone': '918/660-3680', 'title': 'Dr. Nasir Mushtaw', 'organization': 'University of Oklahoma Health Sciences Center Tulsa'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'All study patients were monitored during the entire study period i.e., 2 hours after medication administration.', 'eventGroups': [{'id': 'EG000', 'title': 'Low-FBT', 'description': 'Subject will receive FBT and placebo at a low dose\n\nFentanyl: Fentanyl buccal tablet 100 mcg once', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'High-FBT', 'description': 'Subject will receive the high dose regimen of FBT and a high dose placebo\n\nFentanyl: Fentanyl buccal tablet 200 mcg once', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 9, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Low Control', 'description': 'Subject will receive active oxycodone/APAP 5/325 mg and lansoprazole solutab for the fentanyl "placebo"\n\nOxycodone/acetaminophen: Oxycodone/acetaminophen 5/325 mg once', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 3, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'High Control', 'description': 'Subject will receive the higher dose of the active comparator, #2 oxycodone/APAP 5/325mg, and lansoprazole solutab for the fentanyl "placebo"\n\noxycodone/acetaminophen: Oxycodone/acetaminophen tablet 5/325 mg, 2 tablets one time', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 10, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pruritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Drowsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Median Time to Significant Analgesia (at Least 2 Units Decrease in Pain Level)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-FBT', 'description': 'Subject will receive FBT and placebo at a low dose\n\nFentanyl: Fentanyl buccal tablet 100 mcg once'}, {'id': 'OG001', 'title': 'High-FBT', 'description': 'Subject will receive the high dose regimen of FBT and a high dose placebo\n\nFentanyl: Fentanyl buccal tablet 200 mcg once'}, {'id': 'OG002', 'title': 'Low Control', 'description': 'Subject will receive active oxycodone/APAP 5/325 mg and lansoprazole solutab for the fentanyl "placebo"\n\nOxycodone/acetaminophen: Oxycodone/acetaminophen 5/325 mg once'}, {'id': 'OG003', 'title': 'High Control', 'description': 'Subject will receive the higher dose of the active comparator, #2 oxycodone/APAP 5/325mg, and lansoprazole solutab for the fentanyl "placebo"\n\noxycodone/acetaminophen: Oxycodone/acetaminophen tablet 5/325 mg, 2 tablets one time'}], 'classes': [{'categories': [{'measurements': [{'value': '15.0', 'comment': 'Due to small sample size not enough participants achieved response to calculate upper limit.', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': 'NA'}, {'value': '20.0', 'groupId': 'OG001', 'lowerLimit': '15.0', 'upperLimit': '25.0'}, {'value': '15.0', 'comment': 'Due to small sample size not enough participants achieved response to calculate upper limit.', 'groupId': 'OG002', 'lowerLimit': '5.0', 'upperLimit': 'NA'}, {'value': '15.0', 'groupId': 'OG003', 'lowerLimit': '10.0', 'upperLimit': '25.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '60 minutes', 'description': 'Median time (in minutes) to 2 units decrease in pain level after drug administration. Patients were asked to rate their pain at every 5 minutes intervals from 0 to 60 minutes post drug administration. The 10-point verbally administered numeric pain rating scale (NPRS) was used to have patients rate their level of pain on a scale of 0 (no pain) to 10 (worst pain ever).', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Nausea Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-FBT', 'description': 'Subject will receive FBT and placebo at a low dose\n\nFentanyl: Fentanyl buccal tablet 100 mcg once'}, {'id': 'OG001', 'title': 'High-FBT', 'description': 'Subject will receive the high dose regimen of FBT and a high dose placebo\n\nFentanyl: Fentanyl buccal tablet 200 mcg once'}, {'id': 'OG002', 'title': 'Low Control', 'description': 'Subject will receive active oxycodone/APAP 5/325 mg and lansoprazole solutab for the fentanyl "placebo"\n\nOxycodone/acetaminophen: Oxycodone/acetaminophen 5/325 mg once'}, {'id': 'OG003', 'title': 'High Control', 'description': 'Subject will receive the higher dose of the active comparator, #2 oxycodone/APAP 5/325mg, and lansoprazole solutab for the fentanyl "placebo"\n\noxycodone/acetaminophen: Oxycodone/acetaminophen tablet 5/325 mg, 2 tablets one time'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'every 5 minutes for the first 60 minutes', 'description': "Subjects' nausea level was recorded to determine how fentanyl buccal tablet compares to standard therapy in causing nausea. Treatment induced nausea and severity of nausea level was assessed.\n\nNausea was assessed by a 10-point verbally administered scale. Patients rated their degree of nausea on a scale of 0 (no nausea) to 10 (worst nausea).\n\nAt the beginning of the study, literature review found relatively little evidence guiding objective means to rate nausea, but there was some precedent for this approach (Warden C. Prehospital use of ondansetron reduces nausea and episodes of vomiting in adults and children over 12 years old \\[abstract\\]. Prehosp Emerg Care. 2007;11:132).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing Any Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-FBT', 'description': 'Subject will receive FBT and placebo at a low dose\n\nFentanyl: Fentanyl buccal tablet 100 mcg once'}, {'id': 'OG001', 'title': 'High-FBT', 'description': 'Subject will receive the high dose regimen of FBT and a high dose placebo\n\nFentanyl: Fentanyl buccal tablet 200 mcg once'}, {'id': 'OG002', 'title': 'Low Control', 'description': 'Subject will receive active oxycodone/APAP 5/325 mg and lansoprazole solutab for the fentanyl "placebo"\n\nOxycodone/acetaminophen: Oxycodone/acetaminophen 5/325 mg once'}, {'id': 'OG003', 'title': 'High Control', 'description': 'Subject will receive the higher dose of the active comparator, #2 oxycodone/APAP 5/325mg, and lansoprazole solutab for the fentanyl "placebo"\n\noxycodone/acetaminophen: Oxycodone/acetaminophen tablet 5/325 mg, 2 tablets one time'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Full 2 hours of the study period', 'description': 'Occurrence of any adverse event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Low-FBT', 'description': 'Subject will receive FBT and placebo at a low dose\n\nFentanyl: Fentanyl buccal tablet 100 mcg once'}, {'id': 'FG001', 'title': 'High-FBT', 'description': 'Subject will receive the high dose regimen of FBT and a high dose placebo\n\nFentanyl: Fentanyl buccal tablet 200 mcg once'}, {'id': 'FG002', 'title': 'Low Control', 'description': 'Subject will receive active oxycodone/APAP 5/325 mg and lansoprazole solutab for the fentanyl "placebo"\n\nOxycodone/acetaminophen: Oxycodone/acetaminophen 5/325 mg once'}, {'id': 'FG003', 'title': 'High Control', 'description': 'Subject will receive the higher dose of the active comparator, #2 oxycodone/APAP 5/325mg, and lansoprazole solutab for the fentanyl "placebo"\n\noxycodone/acetaminophen: Oxycodone/acetaminophen tablet 5/325 mg, 2 tablets one time'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Low-FBT', 'description': 'Subject will receive FBT and placebo at a low dose\n\nFentanyl: Fentanyl buccal tablet 100 mcg once'}, {'id': 'BG001', 'title': 'High-FBT', 'description': 'Subject will receive the high dose regimen of FBT and a high dose placebo\n\nFentanyl: Fentanyl buccal tablet 200 mcg once'}, {'id': 'BG002', 'title': 'Low Control', 'description': 'Subject will receive active oxycodone/APAP 5/325 mg and lansoprazole solutab for the fentanyl "placebo"\n\nOxycodone/acetaminophen: Oxycodone/acetaminophen 5/325 mg once'}, {'id': 'BG003', 'title': 'High Control', 'description': 'Subject will receive the higher dose of the active comparator, #2 oxycodone/APAP 5/325mg, and lansoprazole solutab for the fentanyl "placebo"\n\noxycodone/acetaminophen: Oxycodone/acetaminophen tablet 5/325 mg, 2 tablets one time'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '56', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25.5', 'spread': '10.01', 'groupId': 'BG000'}, {'value': '38.4', 'spread': '13.7', 'groupId': 'BG001'}, {'value': '34.0', 'spread': '13.1', 'groupId': 'BG002'}, {'value': '35.4', 'spread': '11.9', 'groupId': 'BG003'}, {'value': '35.6', 'spread': '12.9', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '34', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race/Ethnicity', 'categories': [{'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}]}, {'title': 'Black', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}, {'title': 'American Indian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Hispanic', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-19', 'studyFirstSubmitDate': '2011-01-04', 'resultsFirstSubmitDate': '2017-04-06', 'studyFirstSubmitQcDate': '2011-01-04', 'lastUpdatePostDateStruct': {'date': '2017-06-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-19', 'studyFirstPostDateStruct': {'date': '2011-01-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Median Time to Significant Analgesia (at Least 2 Units Decrease in Pain Level)', 'timeFrame': '60 minutes', 'description': 'Median time (in minutes) to 2 units decrease in pain level after drug administration. Patients were asked to rate their pain at every 5 minutes intervals from 0 to 60 minutes post drug administration. The 10-point verbally administered numeric pain rating scale (NPRS) was used to have patients rate their level of pain on a scale of 0 (no pain) to 10 (worst pain ever).'}], 'secondaryOutcomes': [{'measure': 'Nausea Level', 'timeFrame': 'every 5 minutes for the first 60 minutes', 'description': "Subjects' nausea level was recorded to determine how fentanyl buccal tablet compares to standard therapy in causing nausea. Treatment induced nausea and severity of nausea level was assessed.\n\nNausea was assessed by a 10-point verbally administered scale. Patients rated their degree of nausea on a scale of 0 (no nausea) to 10 (worst nausea).\n\nAt the beginning of the study, literature review found relatively little evidence guiding objective means to rate nausea, but there was some precedent for this approach (Warden C. Prehospital use of ondansetron reduces nausea and episodes of vomiting in adults and children over 12 years old \\[abstract\\]. Prehosp Emerg Care. 2007;11:132)."}, {'measure': 'Number of Participants Experiencing Any Adverse Events', 'timeFrame': 'Full 2 hours of the study period', 'description': 'Occurrence of any adverse event.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Fentanyl buccal tablet'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to evaluate fentanyl buccal tablet (FBT) for analgesia in comparison to standard analgesia, to determine if the FBT allows for faster achievement of "significant analgesia"', 'detailedDescription': 'The subjects/patients will be asked if they would desire a low dose or high dose pain medication regimen. The low dose (low-FBT) group will receive FBT at a dose of 100 mcg, as well as an oral (pill) placebo preparation. The low dose (low-control) group will receive an "inactive comparator" (lansoprazole rapidly-dissolving buccal 15mg, " FBT placebo") and a dose of 5/325 Percocet tablet (oxycodone/acetaminophen 5/325). The high dose (high-FBT) group will receive 200 mcg FBT plus 2 placebo tablets. The high dose (high-control) group will receive the "FBT placebo" and a dose of 2, 5/325 Percocet tablets.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pain sufficient to warrant medication stronger than acetaminophen (Tylenol) or aspirin\n* only if Emergency Department provider approves\n* a negative pregnancy test is required for participation for women of childbearing age\n\nExclusion Criteria:\n\n* If treating provider determines intravenous analgesia is required\n* allergy to acetaminophen or any opiate/opioid, or lansoprazole patients currently taking phenothiazines, CNS depressants (including alcohol), or if they have taken an monoamine oxidase inhibitor (MAOI) or selective serotonin reuptake inhibitor (SSRI) in the past two weeks\n* if patient has already been administered an opioid analgesic for their current injury\n* patients on chronic opioids therapy or a history of opioid abuse\n* breastfeeding mothers\n* patients who plan to drive home after their emergency department visit\n* history of phenylketonuria (due to phenylalanine in the formulation of the lansoprazole solutab)'}, 'identificationModule': {'nctId': 'NCT01270659', 'acronym': 'FAIRTOP II', 'briefTitle': 'Safety and Efficacy Study of Fentanyl Buccal Tablet Use in the Emergency Department for Isolated Extremity Injury', 'organization': {'class': 'OTHER', 'fullName': 'University of Oklahoma'}, 'officialTitle': 'Fentanyl Administered Intraorally for Rapid Treatment of Orthopedic Pain: The FAIRTOP II Trial', 'orgStudyIdInfo': {'id': '1774'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low-FBT', 'description': 'Subject will receive FBT and placebo at a low dose', 'interventionNames': ['Drug: Fentanyl']}, {'type': 'EXPERIMENTAL', 'label': 'High-FBT', 'description': 'Subject will receive the high dose regimen of FBT and a high dose placebo', 'interventionNames': ['Drug: Fentanyl']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low control', 'description': 'Subject will receive active oxycodone/APAP 5/325 mg and lansoprazole solutab for the fentanyl "placebo"', 'interventionNames': ['Drug: Oxycodone/acetaminophen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High control', 'description': 'Subject will receive the higher dose of the active comparator, #2 oxycodone/APAP 5/325mg, and lansoprazole solutab for the fentanyl "placebo"', 'interventionNames': ['Drug: oxycodone/acetaminophen']}], 'interventions': [{'name': 'Fentanyl', 'type': 'DRUG', 'otherNames': ['Fentora 100 mcg buccal tablet'], 'description': 'Fentanyl buccal tablet 100 mcg once', 'armGroupLabels': ['Low-FBT']}, {'name': 'Fentanyl', 'type': 'DRUG', 'otherNames': ['Fentora buccal tablet 200 mcg'], 'description': 'Fentanyl buccal tablet 200 mcg once', 'armGroupLabels': ['High-FBT']}, {'name': 'Oxycodone/acetaminophen', 'type': 'DRUG', 'otherNames': ['Percocet 5/325'], 'description': 'Oxycodone/acetaminophen 5/325 mg once', 'armGroupLabels': ['Low control']}, {'name': 'oxycodone/acetaminophen', 'type': 'DRUG', 'otherNames': ['Percocet 5/325'], 'description': 'Oxycodone/acetaminophen tablet 5/325 mg, 2 tablets one time', 'armGroupLabels': ['High control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74104', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Hillcrest Medical Center Emergency Department', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}], 'overallOfficials': [{'name': 'Stephen H Thomas, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oklahoma'}, {'name': 'Annette O Arthur, PharmD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Oklahoma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oklahoma', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}