Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-27 @ 11:16 PM
Study NCT ID:
NCT03962634
Status:
TERMINATED
Last Update Posted:
2020-11-19
First Post:
2019-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Kovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth - Pediatric
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}, {'id': 'D010485', 'term': 'Periapical Periodontitis'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010483', 'term': 'Periapical Diseases'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D010518', 'term': 'Periodontitis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013748', 'term': 'Tetracaine'}, {'id': 'D010109', 'term': 'Oxymetazoline'}, {'id': 'D002355', 'term': 'Carticaine'}], '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'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'madurantakap@vcu.edu', 'phone': '804-828-4953', 'title': 'Parthasarathy Madurantakam', 'organization': 'Virginia Commonwealth University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 3 hours, the length of the dental procedure', 'eventGroups': [{'id': 'EG000', 'title': 'Kovanaze Nasal Spray (Pediatrics)', 'description': 'Children \\>20 kg who require pulpotomy, restorative procedures, SS crowns in one maxillary tooth\n\nKovanaze Nasal Spray: Intra-nasal local anesthetic', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Articaine Injections (Pediatrics)', 'description': 'Children \\>20 kg who require pulpotomy, restorative procedures, or stainless steel crowns in one maxillary tooth\n\nArticaine Injection: Local anesthetic', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Success Rate of Pupal Anesthesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Kovanaze Nasal Spray (Pediatrics)', 'description': 'Children \\>20 kg who require pulpotomy, restorative procedures, SS crowns in one maxillary tooth\n\nKovanaze Nasal Spray: Intra-nasal local anesthetic'}, {'id': 'OG001', 'title': 'Articaine Injections (Pediatrics)', 'description': 'Children \\>20 kg who require pulpotomy, restorative procedures, or stainless steel crowns in one maxillary tooth\n\nArticaine Injection: Local anesthetic'}], 'timeFrame': 'immediately after dental procedure, an average of 3 hours', 'description': '% dental procedures completed without the need for rescue anesthesia', 'reportingStatus': 'POSTED', 'populationDescription': 'Because of the low number of enrollees with only 1 in the treatment group, results are not reported to protect the confidentiality of the participants'}, {'type': 'SECONDARY', 'title': 'Spread of Anesthesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Kovanaze Nasal Spray (Pediatrics)', 'description': 'Children \\>20 kg who require pulpotomy, restorative procedures, SS crowns in one maxillary tooth\n\nKovanaze Nasal Spray: Intra-nasal local anesthetic'}, {'id': 'OG001', 'title': 'Articaine Injections (Pediatrics)', 'description': 'Children \\>20 kg who require pulpotomy, restorative procedures, or stainless steel crowns in one maxillary tooth\n\nArticaine Injection: Local anesthetic'}], 'timeFrame': 'immediately after dental procedure, an average of 3 hours', 'description': 'Number of teeth anesthetized in maxillary arch', 'reportingStatus': 'POSTED', 'populationDescription': 'Because of the low number of enrollees with only 1 in the treatment group, results are not reported to protect the confidentiality of the participants'}, {'type': 'SECONDARY', 'title': 'Change in Anxiety Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Kovanaze Nasal Spray (Pediatrics)', 'description': 'Children \\>20 kg who require pulpotomy, restorative procedures, SS crowns in one maxillary tooth\n\nKovanaze Nasal Spray: Intra-nasal local anesthetic'}, {'id': 'OG001', 'title': 'Articaine Injections (Pediatrics)', 'description': 'Children \\>20 kg who require pulpotomy, restorative procedures, or stainless steel crowns in one maxillary tooth\n\nArticaine Injection: Local anesthetic'}], 'timeFrame': 'from baseline to immediately after dental procedure', 'description': 'STAI-Y6 - 6 item youth questionnaire assessing anxiety on a 4 point scale ranging from 1 (Not at all) to 4 (very much). Scores range from 6 to 24.', 'reportingStatus': 'POSTED', 'populationDescription': 'Because of the low number of enrollees with only 1 in the treatment group, results are not reported to protect the confidentiality of the participants'}, {'type': 'SECONDARY', 'title': 'Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Kovanaze Nasal Spray (Pediatrics)', 'description': 'Children \\>20 kg who require pulpotomy, restorative procedures, SS crowns in one maxillary tooth\n\nKovanaze Nasal Spray: Intra-nasal local anesthetic'}, {'id': 'OG001', 'title': 'Articaine Injections (Pediatrics)', 'description': 'Children \\>20 kg who require pulpotomy, restorative procedures, or stainless steel crowns in one maxillary tooth\n\nArticaine Injection: Local anesthetic'}], 'timeFrame': 'immediately after dental procedure, an average of 3 hours', 'description': "Venham Behavior rating scale - single item 6 point scale used by provider to rate child's behavior during treatment. Item ranges from 0 (no protest) to 5 (high protest, no cooperation from child)", 'reportingStatus': 'POSTED', 'populationDescription': 'Because of the low number of enrollees with only 1 in the treatment group, results are not reported to protect the confidentiality of the participants'}, {'type': 'SECONDARY', 'title': 'Change in Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Kovanaze Nasal Spray (Pediatrics)', 'description': 'Children \\>20 kg who require pulpotomy, restorative procedures, SS crowns in one maxillary tooth\n\nKovanaze Nasal Spray: Intra-nasal local anesthetic'}, {'id': 'OG001', 'title': 'Articaine Injections (Pediatrics)', 'description': 'Children \\>20 kg who require pulpotomy, restorative procedures, or stainless steel crowns in one maxillary tooth\n\nArticaine Injection: Local anesthetic'}], 'timeFrame': 'from baseline to immediately after dental procedure', 'reportingStatus': 'POSTED', 'populationDescription': 'Because of the low number of enrollees with only 1 in the treatment group, results are not reported to protect the confidentiality of the participants'}, {'type': 'SECONDARY', 'title': 'Change in Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Kovanaze Nasal Spray (Pediatrics)', 'description': 'Children \\>20 kg who require pulpotomy, restorative procedures, SS crowns in one maxillary tooth\n\nKovanaze Nasal Spray: Intra-nasal local anesthetic'}, {'id': 'OG001', 'title': 'Articaine Injections (Pediatrics)', 'description': 'Children \\>20 kg who require pulpotomy, restorative procedures, or stainless steel crowns in one maxillary tooth\n\nArticaine Injection: Local anesthetic'}], 'timeFrame': 'from baseline to immediately after dental procedure', 'reportingStatus': 'POSTED', 'populationDescription': 'Because of the low number of enrollees with only 1 in the treatment group, results are not reported to protect the confidentiality of the participants'}, {'type': 'SECONDARY', 'title': 'Change in Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Kovanaze Nasal Spray (Pediatrics)', 'description': 'Children \\>20 kg who require pulpotomy, restorative procedures, SS crowns in one maxillary tooth\n\nKovanaze Nasal Spray: Intra-nasal local anesthetic'}, {'id': 'OG001', 'title': 'Articaine Injections (Pediatrics)', 'description': 'Children \\>20 kg who require pulpotomy, restorative procedures, or stainless steel crowns in one maxillary tooth\n\nArticaine Injection: Local anesthetic'}], 'timeFrame': 'from baseline to immediately after dental procedure', 'description': 'Emoji scale ranging from 1 (very negative face) to 7 (very positive face)', 'reportingStatus': 'POSTED', 'populationDescription': 'Because of the low number of enrollees with only 1 in the treatment group, results are not reported to protect the confidentiality of the participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Kovanaze Nasal Spray (Pediatrics)', 'description': 'Children \\>20 kg who require pulpotomy, restorative procedures, SS crowns in one maxillary tooth\n\nKovanaze Nasal Spray: Intra-nasal local anesthetic'}, {'id': 'FG001', 'title': 'Articaine Injections (Pediatrics)', 'description': 'Children \\>20 kg who require pulpotomy, restorative procedures, or stainless steel crowns in one maxillary tooth\n\nArticaine Injection: Local anesthetic'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Kovanaze Nasal Spray (Pediatrics)', 'description': 'Children \\>20 kg who require pulpotomy, restorative procedures, SS crowns in one maxillary tooth\n\nKovanaze Nasal Spray: Intra-nasal local anesthetic'}, {'id': 'BG001', 'title': 'Articaine Injections (Pediatrics)', 'description': 'Children \\>20 kg who require pulpotomy, restorative procedures, or stainless steel crowns in one maxillary tooth\n\nArticaine Injection: Local anesthetic'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Because of the low number of enrollees with only 1 in the treatment group, results are not reported to protect the confidentiality of the participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Because of the low number of enrollees with only 1 in the treatment group, results are not reported to protect the confidentiality of the participants', 'unitOfMeasure': 'Participants', 'populationDescription': 'Because of the low number of enrollees with only 1 in the treatment group, results are not reported to protect the confidentiality of the participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Because of the low number of enrollees with only 1 in the treatment group, results are not reported to protect the confidentiality of the participants'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-08-28', 'size': 742638, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-11-13T08:53', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'Drug is no longer being manufactured', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2019-09-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-13', 'studyFirstSubmitDate': '2019-05-21', 'resultsFirstSubmitDate': '2020-10-07', 'studyFirstSubmitQcDate': '2019-05-22', 'lastUpdatePostDateStruct': {'date': '2020-11-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-11-13', 'studyFirstPostDateStruct': {'date': '2019-05-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success Rate of Pupal Anesthesia', 'timeFrame': 'immediately after dental procedure, an average of 3 hours', 'description': '% dental procedures completed without the need for rescue anesthesia'}], 'secondaryOutcomes': [{'measure': 'Spread of Anesthesia', 'timeFrame': 'immediately after dental procedure, an average of 3 hours', 'description': 'Number of teeth anesthetized in maxillary arch'}, {'measure': 'Change in Anxiety Level', 'timeFrame': 'from baseline to immediately after dental procedure', 'description': 'STAI-Y6 - 6 item youth questionnaire assessing anxiety on a 4 point scale ranging from 1 (Not at all) to 4 (very much). Scores range from 6 to 24.'}, {'measure': 'Anxiety', 'timeFrame': 'immediately after dental procedure, an average of 3 hours', 'description': "Venham Behavior rating scale - single item 6 point scale used by provider to rate child's behavior during treatment. Item ranges from 0 (no protest) to 5 (high protest, no cooperation from child)"}, {'measure': 'Change in Blood Pressure', 'timeFrame': 'from baseline to immediately after dental procedure'}, {'measure': 'Change in Heart Rate', 'timeFrame': 'from baseline to immediately after dental procedure'}, {'measure': 'Change in Pain', 'timeFrame': 'from baseline to immediately after dental procedure', 'description': 'Emoji scale ranging from 1 (very negative face) to 7 (very positive face)'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cavities'], 'conditions': ['Caries,Dental', 'Apical Periodontitis']}, 'descriptionModule': {'briefSummary': 'The primary goal of the study is to compare the success rates of pulpal anesthesia (defined as ability to complete the intended dental procedure without the need for rescue anesthesia) between Kovanaze nasal mist and Articaine needle anesthesia.', 'detailedDescription': 'In June 2016, an intranasal delivery system of local anesthesia called Kovanaze, gained FDA approval. \\[9\\] Kovanaze is available as a 0.2 ml metered spray and is intended to achieve pulpal anesthesia of 5 maxillary teeth on either side of the face. Even though success rates between 83 and 90 % have been reported for adults and children \\>40kg, \\[10\\] FDA label (Section 14.2) provides data for children (\\>10 kg) indicating that the drug is safe for use in children as long as the dose is adjusted to bodyweight of the child. \\[9\\]\n\n* One 0.1 mL spray for patients weighing 10 kg to less than 20 kg;\n* Two 0.1 mL sprays for 20 kg to less than 40 kg; or\n* Two 0.2 mL sprays for patients weighing 40 kg or more.\n\nWith the ability to avoid the traditional painful injection Kovanaze offers promise in the field of maxillary anesthesia and this study intends to:\n\n1. Compare Kovanaze to conventional needle anesthetic children (at least 6 years of age and weighing \\> 20 kg)\n2. Evaluate patient anxiety, tolerance and acceptability of Kovanaze in patients undergoing dental procedures'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists Class I or II\n* Preoperative heart rate of 55 to 100 beats per minute\n* Maximum blood pressure reading of 166/100 mmHg\n* Treatment for a pathology in the maxillary anterior tooth or premolar that requires administering local anesthesia\n\nAdditional Pediatric Inclusion Criteria:\n\n* Children \\>20 kg who require pulpotomy, restorative procedures, or stainless steel crowns in one maxillary tooth\n\nAdditional Endodontic Inclusion Criteria:\n\n* Adults (\\>18 years) who require non-surgical root canal treatment in maxillary anterior teeth\n\nAdditional General Practice Inclusion Criteria:\n\n* Adults who require restorations in the maxillary teeth that would need local anesthesia\n\nExclusion Criteria:\n\n* Inadequately controlled thyroid disease\n* Five or more nosebleeds in the past month\n* Known allergy to any study drug or para-aminobenzoic acid\n* History of methemoglobinemia\n* Taking monoamine oxidase inhibitors, tricyclic antidepressants (i.e. amitriptyline), or non-selective beta adrenergic antagonists (i.e. propranolol);\n* Taking oxymetazoline-containing products (i.e., Afrin) in the last 24 hours.'}, 'identificationModule': {'nctId': 'NCT03962634', 'briefTitle': 'Kovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth - Pediatric', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Commonwealth University'}, 'officialTitle': 'Kovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'HM20014136 - pediatric'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Kovanaze Nasal Spray (Pediatrics)', 'description': 'Children \\>20 kg who require pulpotomy, restorative procedures, SS crowns in one maxillary tooth', 'interventionNames': ['Drug: Kovanaze Nasal Spray']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Articaine Injections (Pediatrics)', 'description': 'Children \\>20 kg who require pulpotomy, restorative procedures, or stainless steel crowns in one maxillary tooth', 'interventionNames': ['Drug: Articaine Injection']}], 'interventions': [{'name': 'Kovanaze Nasal Spray', 'type': 'DRUG', 'otherNames': ['Tetracaine HCl, Oxymetazoline HCl, NDC # 69803-100-10'], 'description': 'Intra-nasal local anesthetic', 'armGroupLabels': ['Kovanaze Nasal Spray (Pediatrics)']}, {'name': 'Articaine Injection', 'type': 'DRUG', 'otherNames': ['Septocaine'], 'description': 'Local anesthetic', 'armGroupLabels': ['Articaine Injections (Pediatrics)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Parthasarathy Madurantakam, DDS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Commonwealth University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}