Viewing Study NCT01701505

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
Ignite Creation Date: 2025-12-25 @ 3:26 AM
Ignite Modification Date: 2025-12-31 @ 3:39 AM
Study NCT ID: NCT01701505
Status: COMPLETED
Last Update Posted: 2017-08-30
First Post: 2012-10-02
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Dose-Ranging Study of Intranasal Kovacaine Mist in Pediatric Subjects
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': 'greg@biggrinswithdrgreg.com', 'phone': '970-407-1020', 'title': 'Dr. Gregory D. Evans, DDS', 'organization': 'Big Grins Pediatric Dentistry'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '24 hours post-dosing', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist)', 'description': '120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each', 'otherNumAtRisk': 8, 'otherNumAffected': 6, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist)', 'description': '200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each', 'otherNumAtRisk': 8, 'otherNumAffected': 5, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Cohort A: 12-17 High Dose (400uL Kovacaine Mist)', 'description': '400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each', 'otherNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist)', 'description': '120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each', 'otherNumAtRisk': 8, 'otherNumAffected': 6, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist)', 'description': '200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each', 'otherNumAtRisk': 8, 'otherNumAffected': 7, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist)', 'description': '120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each', 'otherNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nasal Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Nasal Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Rhinalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Sneezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Pharyngeal Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Throat Irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Nasal Dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Oropharyngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Lacrimation Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Abdominal Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Sensory Disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Injection Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Facial Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}, {'term': 'Intranasal Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA15.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist)', 'description': '120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each'}, {'id': 'OG001', 'title': 'Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist)', 'description': '200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each'}, {'id': 'OG002', 'title': 'Cohort A: 12-17 High Dose (400uL Kovacaine Mist)', 'description': '400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each'}, {'id': 'OG003', 'title': 'Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist)', 'description': '120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each'}, {'id': 'OG004', 'title': 'Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist)', 'description': '200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each'}, {'id': 'OG005', 'title': 'Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist)', 'description': '120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at 14 minutes with a 3 minute window', 'description': 'If the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Naris Examination (NE) to Assess Reactions to the Study Drug.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist)', 'description': '120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each'}, {'id': 'OG001', 'title': 'Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist)', 'description': '200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each'}, {'id': 'OG002', 'title': 'Cohort A: 12-17 High Dose (400uL Kovacaine Mist)', 'description': '400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each'}, {'id': 'OG003', 'title': 'Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist)', 'description': '120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each'}, {'id': 'OG004', 'title': 'Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist)', 'description': '200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each'}, {'id': 'OG005', 'title': 'Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist)', 'description': '120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each'}], 'classes': [{'title': 'Post-dose ulceration (not present at baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Post-dose inflammation (not present at baseli', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Post-dose minor bleeding (not present at baseline)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Baseline and 120 Minutes', 'description': 'The principal investigator will perform a visual inspection to note number of participants at post-dose that have a ulceration, inflammation or minor bleeding.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist)', 'description': '120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each'}, {'id': 'OG001', 'title': 'Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist)', 'description': '200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each'}, {'id': 'OG002', 'title': 'Cohort A: 12-17 High Dose (400uL Kovacaine Mist)', 'description': '400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each'}, {'id': 'OG003', 'title': 'Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist)', 'description': '120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each'}, {'id': 'OG004', 'title': 'Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist)', 'description': '200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each'}, {'id': 'OG005', 'title': 'Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist)', 'description': '120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '113.1', 'spread': '8.44', 'groupId': 'OG000'}, {'value': '122.5', 'spread': '11.41', 'groupId': 'OG001'}, {'value': '115.4', 'spread': '10.06', 'groupId': 'OG002'}, {'value': '111.3', 'spread': '7.59', 'groupId': 'OG003'}, {'value': '106.5', 'spread': '9.35', 'groupId': 'OG004'}, {'value': '97.8', 'spread': '8.36', 'groupId': 'OG005'}]}]}, {'title': '12 mins', 'categories': [{'measurements': [{'value': '119.1', 'spread': '12.19', 'groupId': 'OG000'}, {'value': '122.3', 'spread': '10.89', 'groupId': 'OG001'}, {'value': '121.0', 'spread': '21.21', 'groupId': 'OG002'}, {'value': '105.5', 'spread': '13.32', 'groupId': 'OG003'}, {'value': '109.9', 'spread': '6.53', 'groupId': 'OG004'}, {'value': '101.9', 'spread': '10.19', 'groupId': 'OG005'}]}]}, {'title': '120 mins', 'categories': [{'measurements': [{'value': '120.5', 'spread': '9.27', 'groupId': 'OG000'}, {'value': '120.1', 'spread': '10.32', 'groupId': 'OG001'}, {'value': '116.4', 'spread': '9.62', 'groupId': 'OG002'}, {'value': '106.3', 'spread': '8.84', 'groupId': 'OG003'}, {'value': '102.3', 'spread': '9.81', 'groupId': 'OG004'}, {'value': '101.9', 'spread': '16.16', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Baseline, 12 minutes, and 120 minutes', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist)', 'description': '120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each'}, {'id': 'OG001', 'title': 'Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist)', 'description': '200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each'}, {'id': 'OG002', 'title': 'Cohort A: 12-17 High Dose (400uL Kovacaine Mist)', 'description': '400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each'}, {'id': 'OG003', 'title': 'Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist)', 'description': '120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each'}, {'id': 'OG004', 'title': 'Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist)', 'description': '200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each'}, {'id': 'OG005', 'title': 'Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist)', 'description': '120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '64.6', 'spread': '6.93', 'groupId': 'OG000'}, {'value': '70.9', 'spread': '7.16', 'groupId': 'OG001'}, {'value': '62.1', 'spread': '9.37', 'groupId': 'OG002'}, {'value': '65.0', 'spread': '11.71', 'groupId': 'OG003'}, {'value': '63.8', 'spread': '6.96', 'groupId': 'OG004'}, {'value': '61.0', 'spread': '8.19', 'groupId': 'OG005'}]}]}, {'title': '12 mins', 'categories': [{'measurements': [{'value': '63.9', 'spread': '3.40', 'groupId': 'OG000'}, {'value': '68.4', 'spread': '7.85', 'groupId': 'OG001'}, {'value': '66.1', 'spread': '10.96', 'groupId': 'OG002'}, {'value': '62.0', 'spread': '6.78', 'groupId': 'OG003'}, {'value': '64.6', 'spread': '4.78', 'groupId': 'OG004'}, {'value': '60.4', 'spread': '7.93', 'groupId': 'OG005'}]}]}, {'title': '120 mins', 'categories': [{'measurements': [{'value': '64.3', 'spread': '10.67', 'groupId': 'OG000'}, {'value': '69.0', 'spread': '10.57', 'groupId': 'OG001'}, {'value': '70.1', 'spread': '8.51', 'groupId': 'OG002'}, {'value': '65.0', 'spread': '6.41', 'groupId': 'OG003'}, {'value': '61.6', 'spread': '8.47', 'groupId': 'OG004'}, {'value': '66.1', 'spread': '13.58', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Baseline, 12 minutes, and 120 minutes', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist)', 'description': '120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each'}, {'id': 'OG001', 'title': 'Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist)', 'description': '200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each'}, {'id': 'OG002', 'title': 'Cohort A: 12-17 High Dose (400uL Kovacaine Mist)', 'description': '400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each'}, {'id': 'OG003', 'title': 'Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist)', 'description': '120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each'}, {'id': 'OG004', 'title': 'Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist)', 'description': '200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each'}, {'id': 'OG005', 'title': 'Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist)', 'description': '120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '72.9', 'spread': '10.55', 'groupId': 'OG000'}, {'value': '83.6', 'spread': '12.95', 'groupId': 'OG001'}, {'value': '75.5', 'spread': '14.80', 'groupId': 'OG002'}, {'value': '90.3', 'spread': '15.04', 'groupId': 'OG003'}, {'value': '80.6', 'spread': '7.41', 'groupId': 'OG004'}, {'value': '90.1', 'spread': '7.66', 'groupId': 'OG005'}]}]}, {'title': '12 mins', 'categories': [{'measurements': [{'value': '75.4', 'spread': '10.06', 'groupId': 'OG000'}, {'value': '80.9', 'spread': '12.43', 'groupId': 'OG001'}, {'value': '77.3', 'spread': '18.52', 'groupId': 'OG002'}, {'value': '91.6', 'spread': '15.14', 'groupId': 'OG003'}, {'value': '82.5', 'spread': '9.01', 'groupId': 'OG004'}, {'value': '89.3', 'spread': '11.59', 'groupId': 'OG005'}]}]}, {'title': '120 mins', 'categories': [{'measurements': [{'value': '78.4', 'spread': '11.02', 'groupId': 'OG000'}, {'value': '84.3', 'spread': '14.58', 'groupId': 'OG001'}, {'value': '76.1', 'spread': '10.45', 'groupId': 'OG002'}, {'value': '91.9', 'spread': '13.01', 'groupId': 'OG003'}, {'value': '86.9', 'spread': '7.10', 'groupId': 'OG004'}, {'value': '95.0', 'spread': '4.54', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Baseline, 12 minutes, and 120 minutes', 'unitOfMeasure': 'bpm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Oxygen Saturation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist)', 'description': '120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each'}, {'id': 'OG001', 'title': 'Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist)', 'description': '200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each'}, {'id': 'OG002', 'title': 'Cohort A: 12-17 High Dose (400uL Kovacaine Mist)', 'description': '400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each'}, {'id': 'OG003', 'title': 'Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist)', 'description': '120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each'}, {'id': 'OG004', 'title': 'Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist)', 'description': '200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each'}, {'id': 'OG005', 'title': 'Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist)', 'description': '120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '97.3', 'spread': '1.28', 'groupId': 'OG000'}, {'value': '98.8', 'spread': '1.75', 'groupId': 'OG001'}, {'value': '98.3', 'spread': '1.39', 'groupId': 'OG002'}, {'value': '97.3', 'spread': '1.49', 'groupId': 'OG003'}, {'value': '97.4', 'spread': '2.00', 'groupId': 'OG004'}, {'value': '97.6', 'spread': '1.30', 'groupId': 'OG005'}]}]}, {'title': '12 mins', 'categories': [{'measurements': [{'value': '97.3', 'spread': '1.28', 'groupId': 'OG000'}, {'value': '98.3', 'spread': '1.49', 'groupId': 'OG001'}, {'value': '97.9', 'spread': '1.36', 'groupId': 'OG002'}, {'value': '97.4', 'spread': '1.30', 'groupId': 'OG003'}, {'value': '96.3', 'spread': '2.19', 'groupId': 'OG004'}, {'value': '96.4', 'spread': '0.74', 'groupId': 'OG005'}]}]}, {'title': '120 mins', 'categories': [{'measurements': [{'value': '97.0', 'spread': '0.93', 'groupId': 'OG000'}, {'value': '97.4', 'spread': '1.51', 'groupId': 'OG001'}, {'value': '96.9', 'spread': '1.64', 'groupId': 'OG002'}, {'value': '96.0', 'spread': '1.85', 'groupId': 'OG003'}, {'value': '97.5', 'spread': '1.31', 'groupId': 'OG004'}, {'value': '97.5', 'spread': '1.41', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Baseline, 12 minutes, and 120 minutes', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events by Dose Level and Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Kovacaine Mist High Dose', 'description': '400uL of Kovacaine Mist, as 2 sprays of 200uL.\n\n400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each.'}, {'id': 'OG001', 'title': 'Kovacaine Mist Mid Dose', 'description': '200uL of Kovacaine Mist, as 2 sprays of 100uL.\n\n200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each.'}, {'id': 'OG002', 'title': 'Kovacaine Mist Low Dose', 'description': '120uL of Kovacaine Mist, as 2 sprays of 60uL.\n\n120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each.'}], 'classes': [{'title': '3-6 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG002'}]}]}, {'title': '7-11 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': '12-17 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from baseline to 24 hours following drug administration', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients grouped by age'}, {'type': 'SECONDARY', 'title': 'Incidence of Adverse Events by Dose Level Regardless of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Kovacaine Mist High Dose', 'description': '400uL of Kovacaine Mist, as 2 sprays of 200uL.\n\n400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each.'}, {'id': 'OG001', 'title': 'Kovacaine Mist Mid Dose', 'description': '200uL of Kovacaine Mist, as 2 sprays of 100uL.\n\n200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each.'}, {'id': 'OG002', 'title': 'Kovacaine Mist Low Dose', 'description': '120uL of Kovacaine Mist, as 2 sprays of 60uL.\n\n120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from baseline to 24 hours following drug administration', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist)', 'description': '120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each.'}, {'id': 'FG001', 'title': 'Cohort A: 12-17 Years Mid-Dose (200uL Kovacaine Mist)', 'description': '200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each.'}, {'id': 'FG002', 'title': 'Cohort A: 12-17 Years HighDose (400uL Kovacaine Mist)', 'description': '400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each.'}, {'id': 'FG003', 'title': 'Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist)', 'description': '120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each'}, {'id': 'FG004', 'title': 'Cohort B: 7-11 Years Med Dose', 'description': '200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each'}, {'id': 'FG005', 'title': 'Cohort C: 3-6 Years Low Dose', 'description': '120uL of Kovacaine Mist, as 2 sprays of 60uL\n\n120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '48', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist)', 'description': '120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each'}, {'id': 'BG001', 'title': 'Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist)', 'description': '200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each'}, {'id': 'BG002', 'title': 'Cohort A: 12-17 High Dose (400uL Kovacaine Mist)', 'description': '400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each'}, {'id': 'BG003', 'title': 'Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist)', 'description': '120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each'}, {'id': 'BG004', 'title': 'Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist)', 'description': '200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each'}, {'id': 'BG005', 'title': 'Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist)', 'description': '120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '14.3', 'spread': '1.75', 'groupId': 'BG000'}, {'value': '14.4', 'spread': '2.00', 'groupId': 'BG001'}, {'value': '13.6', 'spread': '1.19', 'groupId': 'BG002'}, {'value': '8.9', 'spread': '1.64', 'groupId': 'BG003'}, {'value': '7.9', 'spread': '0.83', 'groupId': 'BG004'}, {'value': '5.3', 'spread': '1.04', 'groupId': 'BG005'}, {'value': '10.7', 'spread': '3.85', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '28', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '20', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '39', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '41', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'dispFirstSubmitDate': '2015-05-15', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-28', 'studyFirstSubmitDate': '2012-10-02', 'dispFirstSubmitQcDate': '2015-05-15', 'resultsFirstSubmitDate': '2016-11-08', 'studyFirstSubmitQcDate': '2012-10-03', 'dispFirstPostDateStruct': {'date': '2015-06-08', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-08-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-07-28', 'studyFirstPostDateStruct': {'date': '2012-10-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic.', 'timeFrame': 'at 14 minutes with a 3 minute window', 'description': 'If the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome.'}], 'secondaryOutcomes': [{'measure': 'Naris Examination (NE) to Assess Reactions to the Study Drug.', 'timeFrame': 'At Baseline and 120 Minutes', 'description': 'The principal investigator will perform a visual inspection to note number of participants at post-dose that have a ulceration, inflammation or minor bleeding.'}, {'measure': 'Systolic Blood Pressure', 'timeFrame': 'At Baseline, 12 minutes, and 120 minutes'}, {'measure': 'Diastolic Blood Pressure', 'timeFrame': 'At Baseline, 12 minutes, and 120 minutes'}, {'measure': 'Heart Rate', 'timeFrame': 'At Baseline, 12 minutes, and 120 minutes'}, {'measure': 'Oxygen Saturation', 'timeFrame': 'At Baseline, 12 minutes, and 120 minutes'}, {'measure': 'Number of Participants With Adverse Events by Dose Level and Age', 'timeFrame': 'from baseline to 24 hours following drug administration'}, {'measure': 'Incidence of Adverse Events by Dose Level Regardless of Age', 'timeFrame': 'from baseline to 24 hours following drug administration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['operative', 'dental procedure'], 'conditions': ['Anesthesia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy and safety of intranasally administered Kovacaine Mist for anesthetizing maxillary teeth in pediatric subjects.', 'detailedDescription': 'This is a single-center, open-label, randomized, parallel-groups, dose-ranging study to assess the efficacy and safety of intranasally administered Kovacaine Mist for anesthetizing maxillary teeth in pediatric subjects.\n\nThe study will employ an open-label design to determine the lowest effective doses (LEDs), and assess the safety and efficacy of Kovacaine Mist administered intranasally for inducing pulpal anesthesia of maxillary primary teeth numbers A to J and maxillary permanent teeth numbers 4 to 13 (maxillary right second premolar to maxillary left second premolar) sufficient to allow completion of the Study Dental Procedure, and will be carried out in healthy children of either sex between the ages of 3 and 17 years, inclusive.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female 3-17 years of age inclusive.\n* Need for an operative restorative dental procedure on a single vital maxillary primary tooth (#A to J) or permanent tooth (#4 to13), other than a maxillary permanent first, second or third molar, requiring local anesthesia with an expected treatment duration not exceeding 60 minutes.\n* Normal lip, nose, eyelid, and cheek sensation.\n* Accompanied and/or represented by a parent or guardian able to comprehend and sign the informed consent document.\n* If age 8 and above, able to understand and provide informed assent.\n* Patient or parent/guardian able to communicate with the investigator and comply with the requirements of the protocol.\n* Patency of the naris ipsilateral to the tooth undergoing the Study Dental Procedure.\n* Minimum weight: Subjects in Cohorts A and B (age 6 and above) must weigh at least 20kg (44 lb.). Subjects in Cohort C (age 3 and above) must weigh at least 10kg (22 lb.).\n\nExclusion Criteria:\n\n* Dental care requiring a local anesthetic within the 24 hours prior to anticipated study participation.\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 lidocaine, 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* Inadequately controlled thyroid disease of any type.\n* Use of any investigational drug (including Kovacaine Mist) and/or participation in any clinical trial within 30 days of study participation.\n* Frequent nose bleeds (≥ 5 per month).\n* Anticipated need for use of 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.\n* Clinically relevant history of sinus/nasal surgery, recent epistaxis, nasal congestion or sinus infections, or use of a "sinus medication" within the 48 hours prior to anticipated study participation.\n* History of alcoholism and/or drug abuse.\n* Pulpal pathology in the index tooth.\n* Anticipated need for use of nitrous oxide before or during the Study Dental Procedure.\n* Any chronic or currently uncontrolled psychogenic, neurological, endocrine, pulmonary, cardiovascular, renal, gastrointestinal or hepatic disease or condition with manifestations that might confound interpretation of study results or make receipt of study medication a source of risk for adverse outcome.\n* Fever defined as body temperature ≥100° (37°C) on the day of and prior to study drug administration.'}, 'identificationModule': {'nctId': 'NCT01701505', 'briefTitle': 'Dose-Ranging Study of Intranasal Kovacaine Mist in Pediatric Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'St. Renatus, LLC'}, 'officialTitle': 'A Phase 2, Single-Center, Open-Label, Randomized, Parallel-Groups, Dose-Ranging Study to Assess the Efficacy and Safety of Intranasally Administered Kovacaine Mist for Anesthetizing Maxillary Teeth in Pediatric Subjects', 'orgStudyIdInfo': {'id': 'SR 2-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Kovacaine Mist High Dose', 'description': '400uL of Kovacaine Mist, as 2 sprays of 200uL.', 'interventionNames': ['Drug: 400uL of Kovacaine Mist']}, {'type': 'EXPERIMENTAL', 'label': 'Kovacaine Mist Mid Dose', 'description': '200uL of Kovacaine Mist, as 2 sprays of 100uL.', 'interventionNames': ['Drug: 200uL of Kovacaine Mist']}, {'type': 'EXPERIMENTAL', 'label': 'Kovacaine Mist Low Dose', 'description': '120uL of Kovacaine Mist, as 2 sprays of 60uL.', 'interventionNames': ['Drug: 120uL of Kovacaine Mist']}], 'interventions': [{'name': '400uL of Kovacaine Mist', 'type': 'DRUG', 'otherNames': ['Tetracaine HCl 3% and Oxymetazoline HCl 0.05%'], 'description': '2 unilateral intranasal sprays of 200uL each.', 'armGroupLabels': ['Kovacaine Mist High Dose']}, {'name': '200uL of Kovacaine Mist', 'type': 'DRUG', 'otherNames': ['Tetracaine HCl 3% and Oxymetazoline HCl 0.05%'], 'description': '2 unilateral intranasal sprays of 100uL each.', 'armGroupLabels': ['Kovacaine Mist Mid Dose']}, {'name': '120uL of Kovacaine Mist', 'type': 'DRUG', 'otherNames': ['Tetracaine HCl 3% and Oxymetazoline HCl 0.05%'], 'description': '2 unilateral intranasal sprays of 60uL each.', 'armGroupLabels': ['Kovacaine Mist Low Dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80525', 'city': 'Fort Collins', 'state': 'Colorado', 'country': 'United States', 'facility': 'Big Grins', 'geoPoint': {'lat': 40.58526, 'lon': -105.08442}}], 'overallOfficials': [{'name': 'Paul A. Moore, DMD/PhD/MPH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Renatus, LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Triligent International', 'class': 'INDUSTRY'}, {'name': 'Rho, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}