Viewing Study NCT01660893

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Ignite Creation Date: 2025-12-25 @ 1:25 AM
Ignite Modification Date: 2026-01-17 @ 10:46 PM
Study NCT ID: NCT01660893
Status: TERMINATED
Last Update Posted: 2017-09-05
First Post: 2012-08-02
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Comparison of Intranasal Kovacaine Mist, Tetracaine Alone, and Placebo for Anesthetizing Maxillary Teeth
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013748', 'term': 'Tetracaine'}], 'ancestors': [{'id': 'D062366', 'term': 'para-Aminobenzoates'}, {'id': 'D062365', 'term': 'Aminobenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sgordon@dental.umaryland.edu', 'phone': '410-706-1656', 'title': 'Dr. Sharon M. Gordon', 'organization': 'University of Maryland'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '24 hours', 'eventGroups': [{'id': 'EG000', 'title': 'Kovacaine Mist, 3 Sprays Unilateral', 'description': 'Tetracaine HCl 3% and oxymetazoline HCl 0.05%\n\nTetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose', 'otherNumAtRisk': 10, 'otherNumAffected': 9, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Tetracaine Only, 3 Sprays Unilateral', 'description': 'Tetracaine HCl 3%\n\nTetracaine HCl 3%: 3 unilateral intranasal sprays per dose', 'otherNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo, 3 Sprays Unilateral', 'description': 'Placebo\n\nPlacebo: 3 unilateral intranasal sprays per dose', 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Oral discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Rhinorrhea', 'notes': 'Runny nose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Nasal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Rhinalgia', 'notes': 'Intranasal stinging or burning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Dysgeusia', 'notes': 'Abnormal taste', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Lacrimation increased', 'notes': 'Tearing or watery eyes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Hypoaesthesia eye', 'notes': 'Numbness around eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Ear discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Pharyngeal Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Sneezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Intranasal Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Anaesthetic Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Completion of the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic (Yes/no).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Kovacaine Mist, 3 Sprays Unilateral', 'description': 'Tetracaine HCl 3% and oxymetazoline HCl 0.05%\n\nTetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose'}, {'id': 'OG001', 'title': 'Tetracaine Only, 3 Sprays Unilateral', 'description': 'Tetracaine HCl 3%\n\nTetracaine HCl 3%: 3 unilateral intranasal sprays per dose'}, {'id': 'OG002', 'title': 'Placebo, 3 Sprays Unilateral', 'description': 'Placebo\n\nPlacebo: 3 unilateral intranasal sprays per dose'}], 'classes': [{'title': 'Success', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Failure', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at 15 minutes with a 3 minute window', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Intraoral Soft-tissue Anesthesia (Yes/no)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Kovacaine Mist, 3 Sprays Unilateral', 'description': 'Tetracaine HCl 3% and oxymetazoline HCl 0.05%\n\nTetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose'}, {'id': 'OG001', 'title': 'Tetracaine Only, 3 Sprays Unilateral', 'description': 'Tetracaine HCl 3%\n\nTetracaine HCl 3%: 3 unilateral intranasal sprays per dose'}, {'id': 'OG002', 'title': 'Placebo, 3 Sprays Unilateral', 'description': 'Placebo\n\nPlacebo: 3 unilateral intranasal sprays per dose'}], 'classes': [{'title': 'Incisive Papilla', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Greater Palatine Foramen', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at 15 minutes with a 3 minute window', 'description': 'Number of patients who reported no pain when incisive papilla and greater palatine foramen soft-tissue was tested with a probe', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Heart Rate Higher Than 125 Bpm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Kovacaine Mist, 3 Sprays Unilateral', 'description': 'Tetracaine HCl 3% and oxymetazoline HCl 0.05%\n\nTetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose'}, {'id': 'OG001', 'title': 'Tetracaine Only, 3 Sprays Unilateral', 'description': 'Tetracaine HCl 3%\n\nTetracaine HCl 3%: 3 unilateral intranasal sprays per dose'}, {'id': 'OG002', 'title': 'Placebo, 3 Sprays Unilateral', 'description': 'Placebo\n\nPlacebo: 3 unilateral intranasal sprays per dose'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at any time within 120 minutes following drug administration', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Heart Rate Lower Than 50 Bpm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Kovacaine Mist, 3 Sprays Unilateral', 'description': 'Tetracaine HCl 3% and oxymetazoline HCl 0.05%\n\nTetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose'}, {'id': 'OG001', 'title': 'Tetracaine Only, 3 Sprays Unilateral', 'description': 'Tetracaine HCl 3%\n\nTetracaine HCl 3%: 3 unilateral intranasal sprays per dose'}, {'id': 'OG002', 'title': 'Placebo, 3 Sprays Unilateral', 'description': 'Placebo\n\nPlacebo: 3 unilateral intranasal sprays per dose'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at any time within 120 minutes following drug administration', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With an Increase From Baseline in Systolic Blood Pressure Greater Than or Equal to 25 mm Hg and to a Value Higher Than 160 mm Hg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Kovacaine Mist, 3 Sprays Unilateral', 'description': 'Tetracaine HCl 3% and oxymetazoline HCl 0.05%\n\nTetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose'}, {'id': 'OG001', 'title': 'Tetracaine Only, 3 Sprays Unilateral', 'description': 'Tetracaine HCl 3%\n\nTetracaine HCl 3%: 3 unilateral intranasal sprays per dose'}, {'id': 'OG002', 'title': 'Placebo, 3 Sprays Unilateral', 'description': 'Placebo\n\nPlacebo: 3 unilateral intranasal sprays per dose'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at any time within 120 minutes following drug administration', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Decrease From Baseline in Systolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Lower Than 90 mm Hg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Kovacaine Mist, 3 Sprays Unilateral', 'description': 'Tetracaine HCl 3% and oxymetazoline HCl 0.05%\n\nTetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose'}, {'id': 'OG001', 'title': 'Tetracaine Only, 3 Sprays Unilateral', 'description': 'Tetracaine HCl 3%\n\nTetracaine HCl 3%: 3 unilateral intranasal sprays per dose'}, {'id': 'OG002', 'title': 'Placebo, 3 Sprays Unilateral', 'description': 'Placebo\n\nPlacebo: 3 unilateral intranasal sprays per dose'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at any time within 120 minutes following drug administration', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With an Increase From Baseline in Diastolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Higher Than 90 mm Hg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Kovacaine Mist, 3 Sprays Unilateral', 'description': 'Tetracaine HCl 3% and oxymetazoline HCl 0.05%\n\nTetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose'}, {'id': 'OG001', 'title': 'Tetracaine Only, 3 Sprays Unilateral', 'description': 'Tetracaine HCl 3%\n\nTetracaine HCl 3%: 3 unilateral intranasal sprays per dose'}, {'id': 'OG002', 'title': 'Placebo, 3 Sprays Unilateral', 'description': 'Placebo\n\nPlacebo: 3 unilateral intranasal sprays per dose'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at any time within 120 minutes following drug administration', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Decrease From Baseline in Diastolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Lower Than 90 mm Hg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Kovacaine Mist, 3 Sprays Unilateral', 'description': 'Tetracaine HCl 3% and oxymetazoline HCl 0.05%\n\nTetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose'}, {'id': 'OG001', 'title': 'Tetracaine Only, 3 Sprays Unilateral', 'description': 'Tetracaine HCl 3%\n\nTetracaine HCl 3%: 3 unilateral intranasal sprays per dose'}, {'id': 'OG002', 'title': 'Placebo, 3 Sprays Unilateral', 'description': 'Placebo\n\nPlacebo: 3 unilateral intranasal sprays per dose'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at any time within 120 minutes following drug administration', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Absolute Maximum Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Kovacaine Mist, 3 Sprays Unilateral', 'description': 'Tetracaine HCl 3% and oxymetazoline HCl 0.05%\n\nTetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose'}, {'id': 'OG001', 'title': 'Tetracaine Only, 3 Sprays Unilateral', 'description': 'Tetracaine HCl 3%\n\nTetracaine HCl 3%: 3 unilateral intranasal sprays per dose'}, {'id': 'OG002', 'title': 'Placebo, 3 Sprays Unilateral', 'description': 'Placebo\n\nPlacebo: 3 unilateral intranasal sprays per dose'}], 'classes': [{'title': 'Systolic Blood Pressure', 'categories': [{'measurements': [{'value': '12.8', 'spread': '6.05', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '8.34', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '7.25', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic Blood Pressure', 'categories': [{'measurements': [{'value': '11.2', 'spread': '5.35', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '4.12', 'groupId': 'OG001'}, {'value': '6.2', 'spread': '8.84', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'from baseline to 120 minutes following drug administration', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Profile Over Time of Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Kovacaine Mist, 3 Sprays Unilateral', 'description': 'Tetracaine HCl 3% and oxymetazoline HCl 0.05%\n\nTetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose'}, {'id': 'OG001', 'title': 'Tetracaine Only, 3 Sprays Unilateral', 'description': 'Tetracaine HCl 3%\n\nTetracaine HCl 3%: 3 unilateral intranasal sprays per dose'}, {'id': 'OG002', 'title': 'Placebo, 3 Sprays Unilateral', 'description': 'Placebo\n\nPlacebo: 3 unilateral intranasal sprays per dose'}], 'classes': [{'title': 'Pre-Study', 'categories': [{'measurements': [{'value': '76.9', 'spread': '9.07', 'groupId': 'OG000'}, {'value': '69.1', 'spread': '7.95', 'groupId': 'OG001'}, {'value': '81.0', 'spread': '8.10', 'groupId': 'OG002'}]}]}, {'title': '10 Minutes', 'categories': [{'measurements': [{'value': '69.6', 'spread': '8.3', 'groupId': 'OG000'}, {'value': '67.1', 'spread': '7.03', 'groupId': 'OG001'}, {'value': '75.8', 'spread': '8.61', 'groupId': 'OG002'}]}]}, {'title': '30 Minutes', 'categories': [{'measurements': [{'value': '64.6', 'spread': '9.48', 'groupId': 'OG000'}, {'value': '64.5', 'spread': '6.36', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not collected as study dental procedure was still ongoing', 'groupId': 'OG002'}]}]}, {'title': '45 Minutes', 'categories': [{'measurements': [{'value': '69.6', 'spread': '8.65', 'groupId': 'OG000'}, {'value': '64.3', 'spread': '5.70', 'groupId': 'OG001'}, {'value': '73.8', 'spread': '8.30', 'groupId': 'OG002'}]}]}, {'title': '60 Minutes', 'categories': [{'measurements': [{'value': '67.3', 'spread': '11.34', 'groupId': 'OG000'}, {'value': '65.3', 'spread': '8.31', 'groupId': 'OG001'}, {'value': '70.2', 'spread': '5.04', 'groupId': 'OG002'}]}]}, {'title': '90 Minutes', 'categories': [{'measurements': [{'value': '67.1', 'spread': '7.74', 'groupId': 'OG000'}, {'value': '64.3', 'spread': '8.39', 'groupId': 'OG001'}, {'value': '72.0', 'spread': '7.56', 'groupId': 'OG002'}]}]}, {'title': '120 Minutes', 'categories': [{'measurements': [{'value': '68.4', 'spread': '6.31', 'groupId': 'OG000'}, {'value': '65.0', 'spread': '8.43', 'groupId': 'OG001'}, {'value': '70.8', 'spread': '7.57', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'from baseline to 120 minutes following drug administration', 'unitOfMeasure': 'bpm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Alcohol Sniff Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Kovacaine Mist, 3 Sprays Unilateral', 'description': 'Tetracaine HCl 3% and oxymetazoline HCl 0.05%\n\nTetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose'}, {'id': 'OG001', 'title': 'Tetracaine Only, 3 Sprays Unilateral', 'description': 'Tetracaine HCl 3%\n\nTetracaine HCl 3%: 3 unilateral intranasal sprays per dose'}, {'id': 'OG002', 'title': 'Placebo, 3 Sprays Unilateral', 'description': 'Placebo\n\nPlacebo: 3 unilateral intranasal sprays per dose'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'spread': '5.44', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '7.69', 'groupId': 'OG001'}, {'value': '2.1', 'spread': '2.94', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'administered at approximately 24 hours after drug administration', 'description': 'The change from screening in the the distance from the nose (in centimeters) that a patient is able to detect the smell of an alcohol swab.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Profile Over Time of Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Kovacaine Mist, 3 Sprays Unilateral', 'description': 'Tetracaine HCl 3% and oxymetazoline HCl 0.05%\n\nTetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose'}, {'id': 'OG001', 'title': 'Tetracaine Only, 3 Sprays Unilateral', 'description': 'Tetracaine HCl 3%\n\nTetracaine HCl 3%: 3 unilateral intranasal sprays per dose'}, {'id': 'OG002', 'title': 'Placebo, 3 Sprays Unilateral', 'description': 'Placebo\n\nPlacebo: 3 unilateral intranasal sprays per dose'}], 'classes': [{'title': 'Pre-Study', 'categories': [{'measurements': [{'value': '113.0', 'spread': '8.23', 'groupId': 'OG000'}, {'value': '116.1', 'spread': '11.0', 'groupId': 'OG001'}, {'value': '125.5', 'spread': '6.19', 'groupId': 'OG002'}]}]}, {'title': '10 Minutes', 'categories': [{'measurements': [{'value': '116.5', 'spread': '6.82', 'groupId': 'OG000'}, {'value': '114.2', 'spread': '5.51', 'groupId': 'OG001'}, {'value': '118.8', 'spread': '8.77', 'groupId': 'OG002'}]}]}, {'title': '30 Minutes', 'categories': [{'measurements': [{'value': '123.0', 'spread': '11.34', 'groupId': 'OG000'}, {'value': '110.0', 'spread': '4.24', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not collected as study dental procedure was still ongoing', 'groupId': 'OG002'}]}]}, {'title': '45 Minutes', 'categories': [{'measurements': [{'value': '118.5', 'spread': '9.26', 'groupId': 'OG000'}, {'value': '113.6', 'spread': '9.31', 'groupId': 'OG001'}, {'value': '118.8', 'spread': '10.44', 'groupId': 'OG002'}]}]}, {'title': '60 Minutes', 'categories': [{'measurements': [{'value': '116.1', 'spread': '9.68', 'groupId': 'OG000'}, {'value': '113.3', 'spread': '7.27', 'groupId': 'OG001'}, {'value': '121.7', 'spread': '12.39', 'groupId': 'OG002'}]}]}, {'title': '90 Minutes', 'categories': [{'measurements': [{'value': '117.7', 'spread': '8.34', 'groupId': 'OG000'}, {'value': '112.0', 'spread': '6.93', 'groupId': 'OG001'}, {'value': '119.7', 'spread': '8.89', 'groupId': 'OG002'}]}]}, {'title': '120 Minutes', 'categories': [{'measurements': [{'value': '119.5', 'spread': '10.89', 'groupId': 'OG000'}, {'value': '113.7', 'spread': '9.31', 'groupId': 'OG001'}, {'value': '119.2', 'spread': '9.50', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'from baseline to 120 minutes following drug administration', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Profile Over Time of Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Kovacaine Mist, 3 Sprays Unilateral', 'description': 'Tetracaine HCl 3% and oxymetazoline HCl 0.05%\n\nTetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose'}, {'id': 'OG001', 'title': 'Tetracaine Only, 3 Sprays Unilateral', 'description': 'Tetracaine HCl 3%\n\nTetracaine HCl 3%: 3 unilateral intranasal sprays per dose'}, {'id': 'OG002', 'title': 'Placebo, 3 Sprays Unilateral', 'description': 'Placebo\n\nPlacebo: 3 unilateral intranasal sprays per dose'}], 'classes': [{'title': 'Pre-Study', 'categories': [{'measurements': [{'value': '74.1', 'spread': '5.09', 'groupId': 'OG000'}, {'value': '73.0', 'spread': '7.09', 'groupId': 'OG001'}, {'value': '77.7', 'spread': '7.17', 'groupId': 'OG002'}]}]}, {'title': '10 Minutes', 'categories': [{'measurements': [{'value': '77.9', 'spread': '7.06', 'groupId': 'OG000'}, {'value': '73.8', 'spread': '5.65', 'groupId': 'OG001'}, {'value': '75.5', 'spread': '4.23', 'groupId': 'OG002'}]}]}, {'title': '30 Minutes', 'categories': [{'measurements': [{'value': '81.0', 'spread': '6.96', 'groupId': 'OG000'}, {'value': '70.0', 'spread': '1.41', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not collected as study dental procedure was still ongoing', 'groupId': 'OG002'}]}]}, {'title': '45 Minutes', 'categories': [{'measurements': [{'value': '76.4', 'spread': '5.8', 'groupId': 'OG000'}, {'value': '72.2', 'spread': '6.03', 'groupId': 'OG001'}, {'value': '74.2', 'spread': '7.81', 'groupId': 'OG002'}]}]}, {'title': '60 Minutes', 'categories': [{'measurements': [{'value': '76.1', 'spread': '6.62', 'groupId': 'OG000'}, {'value': '75.9', 'spread': '6.52', 'groupId': 'OG001'}, {'value': '77.8', 'spread': '7.68', 'groupId': 'OG002'}]}]}, {'title': '90 Minutes', 'categories': [{'measurements': [{'value': '80.5', 'spread': '8.78', 'groupId': 'OG000'}, {'value': '73.1', 'spread': '6.40', 'groupId': 'OG001'}, {'value': '78.8', 'spread': '7.28', 'groupId': 'OG002'}]}]}, {'title': '120 Minutes', 'categories': [{'measurements': [{'value': '79.1', 'spread': '10.91', 'groupId': 'OG000'}, {'value': '72.1', 'spread': '8.13', 'groupId': 'OG001'}, {'value': '77.7', 'spread': '8.55', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'from baseline to 120 minutes following drug administration', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Absolute Maximum Change From Baseline in Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Kovacaine Mist, 3 Sprays Unilateral', 'description': 'Tetracaine HCl 3% and oxymetazoline HCl 0.05%\n\nTetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose'}, {'id': 'OG001', 'title': 'Tetracaine Only, 3 Sprays Unilateral', 'description': 'Tetracaine HCl 3%\n\nTetracaine HCl 3%: 3 unilateral intranasal sprays per dose'}, {'id': 'OG002', 'title': 'Placebo, 3 Sprays Unilateral', 'description': 'Placebo\n\nPlacebo: 3 unilateral intranasal sprays per dose'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'spread': '8.62', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '7.09', 'groupId': 'OG001'}, {'value': '2.3', 'spread': '7.55', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'from baseline to 120 minutes following drug administration', 'unitOfMeasure': 'bpm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Kovacaine Mist, 3 Sprays Unilateral', 'description': 'Tetracaine HCl 3% and oxymetazoline HCl 0.05%\n\nTetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose'}, {'id': 'FG001', 'title': 'Tetracaine Only, 3 Sprays Unilateral', 'description': 'Tetracaine HCl 3%\n\nTetracaine HCl 3%: 3 unilateral intranasal sprays per dose'}, {'id': 'FG002', 'title': 'Placebo, 3 Sprays Unilateral', 'description': 'Placebo\n\nPlacebo: 3 unilateral intranasal sprays per dose'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Kovacaine Mist, 3 Sprays Unilateral', 'description': 'Tetracaine HCl 3% and oxymetazoline HCl 0.05%\n\nTetracaine HCl 3% and oxymetazoline HCl 0.05%: 3 unilateral intranasal sprays per dose'}, {'id': 'BG001', 'title': 'Tetracaine Only, 3 Sprays Unilateral', 'description': 'Tetracaine HCl 3%\n\nTetracaine HCl 3%: 3 unilateral intranasal sprays per dose'}, {'id': 'BG002', 'title': 'Placebo, 3 Sprays Unilateral', 'description': 'Placebo\n\nPlacebo: 3 unilateral intranasal sprays per dose'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.3', 'spread': '10.22', 'groupId': 'BG000'}, {'value': '33.3', 'spread': '11.10', 'groupId': 'BG001'}, {'value': '32.7', 'spread': '9.85', 'groupId': 'BG002'}, {'value': '32.4', 'spread': '10.11', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], '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': '6', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'dispFirstSubmitDate': '2015-05-15', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-01', 'studyFirstSubmitDate': '2012-08-02', 'dispFirstSubmitQcDate': '2015-05-15', 'resultsFirstSubmitDate': '2016-10-06', 'studyFirstSubmitQcDate': '2012-08-08', 'dispFirstPostDateStruct': {'date': '2015-06-08', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-09-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-01', 'studyFirstPostDateStruct': {'date': '2012-08-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Completion of the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic (Yes/no).', 'timeFrame': 'at 15 minutes with a 3 minute window'}], 'secondaryOutcomes': [{'measure': 'Intraoral Soft-tissue Anesthesia (Yes/no)', 'timeFrame': 'at 15 minutes with a 3 minute window', 'description': 'Number of patients who reported no pain when incisive papilla and greater palatine foramen soft-tissue was tested with a probe'}, {'measure': 'Number of Participants With Heart Rate Higher Than 125 Bpm', 'timeFrame': 'at any time within 120 minutes following drug administration'}, {'measure': 'Number of Participants With Heart Rate Lower Than 50 Bpm', 'timeFrame': 'at any time within 120 minutes following drug administration'}, {'measure': 'Number of Participants With an Increase From Baseline in Systolic Blood Pressure Greater Than or Equal to 25 mm Hg and to a Value Higher Than 160 mm Hg', 'timeFrame': 'at any time within 120 minutes following drug administration'}, {'measure': 'Number of Participants With a Decrease From Baseline in Systolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Lower Than 90 mm Hg', 'timeFrame': 'at any time within 120 minutes following drug administration'}, {'measure': 'Number of Participants With an Increase From Baseline in Diastolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Higher Than 90 mm Hg', 'timeFrame': 'at any time within 120 minutes following drug administration'}, {'measure': 'Number of Participants With a Decrease From Baseline in Diastolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Lower Than 90 mm Hg', 'timeFrame': 'at any time within 120 minutes following drug administration'}, {'measure': 'Absolute Maximum Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure', 'timeFrame': 'from baseline to 120 minutes following drug administration'}, {'measure': 'The Profile Over Time of Heart Rate', 'timeFrame': 'from baseline to 120 minutes following drug administration'}, {'measure': 'Alcohol Sniff Test', 'timeFrame': 'administered at approximately 24 hours after drug administration', 'description': 'The change from screening in the the distance from the nose (in centimeters) that a patient is able to detect the smell of an alcohol swab.'}, {'measure': 'The Profile Over Time of Systolic Blood Pressure', 'timeFrame': 'from baseline to 120 minutes following drug administration'}, {'measure': 'The Profile Over Time of Diastolic Blood Pressure', 'timeFrame': 'from baseline to 120 minutes following drug administration'}, {'measure': 'Absolute Maximum Change From Baseline in Heart Rate', 'timeFrame': 'from baseline to 120 minutes following drug administration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['operative', 'dental procedure'], 'conditions': ['Anesthesia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy of Kovacaine Mist, Tetracaine only, and Placebo for inducing pulpal anesthesia of the maxillary teeth in adults.', 'detailedDescription': 'The study will employ a multi-center, randomized, double-blind, placebo-controlled, parallel-groups design to assess the safety and efficacy of Kovacaine Mist delivered intranasally for inducing pulpal anesthesia of maxillary teeth numbers 4 to 13 (maxillary right second premolar to maxillary left second premolar) sufficient to allow completion of the Study Dental Procedure.\n\nA total of 140 subjects, randomized 2:2:1 (Kovacaine Mist:Tetracaine alone:Placebo) will be enrolled to achieve 125 completed subjects; a total of 50 Kovacaine Mist subjects, 50 tetracaine alone subjects and 25 placebo subjects. Recruitment will be from diverse dental patient populations. At the two study sites, a balanced enrollment of 70 subjects each is planned to allow for a potential 10% drop-out rate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female 18 years of age or older.\n* Need for an operative restorative dental procedure requiring local anesthesia for a single vital maxillary tooth (other than a maxillary first, second, or third molar) with no evidence of pulpal pathology.\n* Normal lip, nose, eyelid, and cheek sensation.\n* Able to understand and sign the study informed consent document, communicate with the investigators, and understand and comply with the requirements of the protocol.\n* Patency of the naris ipsilateral to the tooth undergoing the Study Dental Procedure.\n* Resting heart rate (HR) between 55 and 100 beats per minute (bpm), inclusive.\n* Seated systolic blood pressure (SBP) between 95 and 140 mm Hg, inclusive and seated diastolic blood pressure (DBP) between 60 and 90 mm Hg, inclusive.\n\nExclusion Criteria:\n\n* Inadequately controlled hypertension (blood pressure greater than 140/90 mm Hg).\n* Inadequately controlled active thyroid disease of any type.\n* Frequent nose bleeds (≥ 5 per month).\n* Having received dental care requiring a local anesthetic within the last 24 hours.\n* History of allergy to or intolerance of tetracaine, benzyl alcohol, other ester local anesthetics, or para-aminobenzoic acid (as found in PABA-containing sunscreen).\n* History of allergy or hypersensitivity to articaine, oxymetazoline, epinephrine, or sulfite preservatives.\n* Use of a monoamine oxidase inhibitor within the 3 weeks preceding study entry.\n* Nursing, pregnant, suspected of being pregnant, or trying to become pregnant. (Females of child-bearing potential will be required to take a urine pregnancy test on the day of, but prior to, study drug administration to rule out pregnancy.)\n* Having received any investigational drug and/or participation in any clinical trial within 30 days prior to study participation.\n* Having used oxymetazoline or phenylephrine nasal spray, nasal irrigation, or other nasal or oral decongestant on the day of the study procedure.\n* History of congenital or idiopathic methemoglobinemia'}, 'identificationModule': {'nctId': 'NCT01660893', 'briefTitle': 'Comparison of Intranasal Kovacaine Mist, Tetracaine Alone, and Placebo for Anesthetizing Maxillary Teeth', 'organization': {'class': 'INDUSTRY', 'fullName': 'St. Renatus, LLC'}, 'officialTitle': 'A Phase III, Multi-Center, Randomized, Double-Blind, Parallel-Groups Clinical Trial Comparing the Efficacy and Safety of Intranasally Administered Kovacaine Mist to Tetracaine Alone and to Placebo for Anesthetizing Maxillary Teeth in Adults', 'orgStudyIdInfo': {'id': 'SR 3-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Kovacaine Mist, 3 sprays unilateral', 'description': 'Tetracaine HCl 3% and oxymetazoline HCl 0.05%', 'interventionNames': ['Drug: Tetracaine HCl 3% and oxymetazoline HCl 0.05%']}, {'type': 'EXPERIMENTAL', 'label': 'Tetracaine Only, 3 sprays unilateral', 'description': 'Tetracaine HCl 3%', 'interventionNames': ['Drug: Tetracaine HCl 3%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo, 3 sprays unilateral', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tetracaine HCl 3% and oxymetazoline HCl 0.05%', 'type': 'DRUG', 'otherNames': ['Kovacaine Mist'], 'description': '3 unilateral intranasal sprays per dose', 'armGroupLabels': ['Kovacaine Mist, 3 sprays unilateral']}, {'name': 'Tetracaine HCl 3%', 'type': 'DRUG', 'description': '3 unilateral intranasal sprays per dose', 'armGroupLabels': ['Tetracaine Only, 3 sprays unilateral']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '3 unilateral intranasal sprays per dose', 'armGroupLabels': ['Placebo, 3 sprays unilateral']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20740', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland, Baltimore', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '84124', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Family and Cosmetic Dentistry', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84124', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Jean Brown Research', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Paul A. Moore, DMD/PhD/MPH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Pittsburgh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Renatus, LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Triligent International', 'class': 'INDUSTRY'}, {'name': 'Rho, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}