Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2025-12-30 @ 3:34 PM
Study NCT ID:
NCT00685295
Status:
COMPLETED
Last Update Posted:
2017-02-09
First Post:
2008-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Fentanyl Administered Intraorally for Rapid Treatment of Orthopedic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D013180', 'term': 'Sprains and Strains'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D064747', 'term': 'Lansoprazole'}, {'id': 'D010098', 'term': 'Oxycodone'}, {'id': 'C514822', 'term': 'oxycodone-acetaminophen'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003061', 'term': 'Codeine'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sthomasmd@gmail.com', 'phone': '6177267622', 'title': 'Stephen Thomas', 'organization': 'Harvard/MGH'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 day after enrollment, subjects were contacted', 'eventGroups': [{'id': 'EG000', 'title': 'Arm 1 / Fentora', 'description': 'Subject receives placebo swallowed pill, and Fentora 100mcg rapidly dissolving transbuccal tablet', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Arm 2 / Percocet/Prevacid', 'description': 'Subject receives Percocet swallowed pill, and Prevacid comparator rapidly dissolving transbuccal tablet', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Analgesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 / Fentora', 'description': 'Subject receives placebo swallowed pill, and Fentora 100mcg rapidly dissolving transbuccal tablet'}, {'id': 'OG001', 'title': 'Arm 2 / Percocet/Prevacid', 'description': 'Subject receives Percocet swallowed pill, and Prevacid comparator rapidly dissolving transbuccal tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '15'}, {'value': '35', 'groupId': 'OG001', 'lowerLimit': '20', 'upperLimit': '40'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '60 minutes', 'description': 'Time it took for subjects to achieve a pain score reduction of 2 units (on a 0 to 10 scale)', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Pain Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 / Fentora', 'description': 'Subject receives placebo swallowed pill, and Fentora 100mcg rapidly dissolving transbuccal tablet'}, {'id': 'OG001', 'title': 'Arm 2 / Percocet/Prevacid', 'description': 'Subject receives Percocet swallowed pill, and Prevacid comparator rapidly dissolving transbuccal tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '60 minutes', 'description': 'Number of subjects who reached pain reduction. A subject was deemed to have reached pain reduction if there was a two-point drop in pain scale (0-10).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Occurrence of Untoward Opioid Side Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1 / Fentora', 'description': 'Intervention Group:\n\nSubject receives:\n\n1. placebo oral/swallowed pill\n2. Fentanyl (Fentora) 100mcg rapidly dissolving transbuccal tablet\n\nFentanyl: Fentanyl rapid dissolving tablet 100mcg'}, {'id': 'OG001', 'title': 'Arm 2 / Percocet/Prevacid', 'description': 'Active Comparator Group:\n\nSubject receives:\n\n1. Oxycodone/APAP (Percocet) 5/325 mg oral/swallowed pill\n2. Lansoprazole 15 mg (Prevacid) comparator rapidly dissolving transbuccal tablet\n\nLansoprazole: lansoprazole 15mg rapidly dissolving tablet\n\nOxycodone: Oxycodone 5/325 mg tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '120 minutes', 'description': 'Subjects were monitored for any signs of untoward opioid side effects.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm 1 / Fentora', 'description': 'Subject receives placebo swallowed pill, and Fentora 100mcg rapidly dissolving transbuccal tablet'}, {'id': 'FG001', 'title': 'Arm 2 / Percocet/Prevacid', 'description': 'Subject receives Percocet swallowed pill, and Prevacid comparator rapidly dissolving transbuccal tablet'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm 1 / Fentora', 'description': 'Subject receives placebo swallowed pill, and Fentora 100mcg rapidly dissolving transbuccal tablet'}, {'id': 'BG001', 'title': 'Arm 2 / Percocet/Prevacid', 'description': 'Subject receives Percocet swallowed pill, and Prevacid comparator rapidly dissolving transbuccal 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': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29', 'spread': '8', 'groupId': 'BG000'}, {'value': '30', 'spread': '12', 'groupId': 'BG001'}, {'value': '30', 'spread': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60.0', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-17', 'studyFirstSubmitDate': '2008-05-23', 'resultsFirstSubmitDate': '2009-02-25', 'studyFirstSubmitQcDate': '2008-05-27', 'lastUpdatePostDateStruct': {'date': '2017-02-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-12-17', 'studyFirstPostDateStruct': {'date': '2008-05-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Analgesia', 'timeFrame': '60 minutes', 'description': 'Time it took for subjects to achieve a pain score reduction of 2 units (on a 0 to 10 scale)'}, {'measure': 'Pain Reduction', 'timeFrame': '60 minutes', 'description': 'Number of subjects who reached pain reduction. A subject was deemed to have reached pain reduction if there was a two-point drop in pain scale (0-10).'}], 'secondaryOutcomes': [{'measure': 'Occurrence of Untoward Opioid Side Effects', 'timeFrame': '120 minutes', 'description': 'Subjects were monitored for any signs of untoward opioid side effects.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Emergency Department', 'acute'], 'conditions': ['Pain, Fracture, Sprain']}, 'descriptionModule': {'briefSummary': 'Assess whether transbuccal fentanyl provides more rapid relief of orthopedic pain, than does the comparator Percocet', 'detailedDescription': 'Patients will be initially deemed eligible for study consideration if, after MGH ED nursing triage, an X-ray is ordered for suspected isolated extremity injury and the triage acuity level is "Minor". Study staff (physicians) will monitor the ED registration and triage areas to assess whether triaged patients are potentially eligible.\n\nFor ED patients with minor isolated injuries, X-rays are often ordered from triage, where there is a supervising physician (or nurse practitioner) available to examine patients and direct care. Either at triage (for patients undergoing care at that location) or when patients are moved to the ED\'s Minor Surgery area, the supervising healthcare provider will be approached immediately after that individual\'s evaluation of the patient, and before any pain medication is administered, to begin the process of eligibility ascertainment.\n\nIf the provider agrees that the patient may be a candidate for the study, the next step will be for the provider to ask the patient if study staff may approach to discuss the trial.\n\nIf the patient agrees to have study staff approach to discuss the trial, study personnel (all EM resident or Attending-level physicians) will be introduced by healthcare providers to potential subjects. Study staff will then converse with the patients about the study\'s aims, methodology, and risks, confirming eligibility and determining if patients will consent to participate.\n\nPatients who are approached, but who are determined to be ineligible, will have no data recorded, other than their age and race/ethnicity and the reason they were ineligible.\n\nIf eligible patients provide written consent in the manner and form dictated by Partners guidelines, the study procedures will commence.\n\nFor eligible patients who do not give consent, study physicians will emphasize that patient care will be unaffected by their decision. No further contact will occur between study staff and those patients. No identifying information about such patients will be recorded, but their age and race/ethnicity will be recorded. (Recording this information will allow for subsequent assessment for selection bias, and will also help search for patterns in patient types refusing analgesia trial participation.)\n\nThe actual medication administration will involve the following steps:\n\n1. Patients participating in the study will be identified and placed in a "room" (stretcher or actual ED room) in the MGH ED\'s Minor Multipurpose (MIMP) area;\n2. RNs will obtain the study medication pairs (buccal tablet + oral tablet) from the computerized medication storage area - RNs will take the next-numbered medication pair from the MGH Research Pharmacy-prepared drug packaging;\n3. Actual medications will be administered by a licensed physician (a study co-investigator, EM resident or Attending physician at MGH), who is not the co-investigator monitoring the patient for endpoint assessment - the physician administering the medication/placebo will inform neither the patient nor the clinical or study staff, the identity of the medication/placebo pair given.\n\nPatients will be monitored by a study physician co-investigator physically present with the patient, for a total of 120 minutes after administration of medication. They will be asked q-5-minutes, through 60 minutes, to rate their pain and degree of nausea, as well as to describe any adverse reactions to the medication. Both pain and nausea levels will be recorded using 10-point scales. Use of such scales is common in the pain literature, and is an emerging tool for evaluation of nausea.1,2 Data collection for analgesia efficacy will cease after 60 minutes, but patients will be monitored for at least another 60 minutes to maximize safety; patients will be assessed for discharge suitability by treating clinicians/nurses in the same fashion as other ED patients who receive opioids.\n\nVital signs (respiratory rate, blood pressure, heart rate, pulse oximetry) will be monitored for the two hours of the study. Continuous pulse oximetry will be used during the first study hour, and q5-minute spot-check pulse oximetry will be used during the second study hour; pulse oximetry monitoring will be changed to continuous mode during the second study hour if any spot-check reading falls below 98%. Other (non-pulse oximetry) vital signs will be monitored q5-minutes during the first study hour, and q15-minutes during the second study hour. These vital signs monitoring parameters represent the minimum for study subjects; treating clinicians or study staff physicians can increase the frequency of vital signs monitoring at their discretion. Any study subject not admitted to the hospital, will be discharged under the care of a responsible adult.\n\nAt the conclusion of the data collection period, patients will be asked if they would want to receive the same medication in the future. Other than a 24-hour telephone call (made only if patients agree), intended to assess for delayed problems such as nausea/vomiting, there will be no other study procedures or interventions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "INCLUSION:\n\n* 18-60 years of age\n* Present to ED with a chief complaint of extremity injury\n* Negative pregnancy test (urine or blood)\n* Clinician judges subject to need extremity radiography to rule out a fracture\n* Subjects must indicate that their pain is of sufficient severity to warrant treatment with a pain medication stronger than acetaminophen or aspirin.\n* Subject's treating ED provider is aware of, and approves, participation (i.e. participation cannot be allowed to impair provision of standard patient care).\n\nEXCLUSION:\n\n* Treating provider judges that IV analgesia is required\n* Allergy to acetaminophen or to any opiate/opioid\n* Currently taking phenothiazines or CNS depressants (including alcohol), or if subject has taken MAO inhibitors or SSRIs within the past two weeks\n* Already taken or been administered opioid analgesia for their current injury\n* Chronic opioid therapy or if the subject (or their medical records) indicate a history of opioid abuse\n* Breastfeeding mothers\n* If subject is planning to drive home after their ED visit, or if they are judged for any other reason to be non-candidates for opioid therapy.\n* hypersensitivity to lansoprazole\n* phenylketonuria"}, 'identificationModule': {'nctId': 'NCT00685295', 'acronym': 'FAIRTOP', 'briefTitle': 'Fentanyl Administered Intraorally for Rapid Treatment of Orthopedic Pain', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Fentanyl Administered Intraorally for Rapid Treatment of Orthopedic Pain in the ED', 'orgStudyIdInfo': {'id': 'FAIRTOP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1 / Fentora', 'description': 'Intervention Group:\n\nSubject receives:\n\n1. placebo oral/swallowed pill\n2. Fentanyl (Fentora) 100mcg rapidly dissolving transbuccal tablet', 'interventionNames': ['Drug: Fentanyl']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2 / Percocet/Prevacid', 'description': 'Active Comparator Group:\n\nSubject receives:\n\n1. Oxycodone/APAP (Percocet) 5/325 mg oral/swallowed pill\n2. Lansoprazole 15 mg (Prevacid) comparator rapidly dissolving transbuccal tablet', 'interventionNames': ['Drug: Lansoprazole', 'Drug: Oxycodone']}], 'interventions': [{'name': 'Fentanyl', 'type': 'DRUG', 'otherNames': ['Fentora'], 'description': 'Fentanyl rapid dissolving tablet 100mcg', 'armGroupLabels': ['Arm 1 / Fentora']}, {'name': 'Lansoprazole', 'type': 'DRUG', 'otherNames': ['Prevacid SoluTab'], 'description': 'lansoprazole 15mg rapidly dissolving tablet', 'armGroupLabels': ['Arm 2 / Percocet/Prevacid']}, {'name': 'Oxycodone', 'type': 'DRUG', 'otherNames': ['Percocet'], 'description': 'Oxycodone 5/325 mg tablet', 'armGroupLabels': ['Arm 2 / Percocet/Prevacid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Stephen H Thomas, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to make individual participant data available to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending Physician', 'investigatorFullName': 'Stephen H. Thomas, MD MPH', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}