Ignite Creation Date:
2025-12-24 @ 2:47 PM
Ignite Modification Date:
2026-01-12 @ 5:19 AM
Study NCT ID:
NCT02600559
Status:
COMPLETED
Last Update Posted:
2020-10-19
First Post:
2015-11-05
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010033', 'term': 'Otitis Media'}, {'id': 'D010031', 'term': 'Otitis'}], 'ancestors': [{'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002939', 'term': 'Ciprofloxacin'}], 'ancestors': [{'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@otonomy.com', 'phone': '1-800-826-6411', 'title': 'Medical Information Call Center', 'organization': 'Otonomy, Inc.'}, 'certainAgreement': {'otherDetails': 'Publication subject to Sponsor consent.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were reported during dosing and up to 2 months following tympanostomy tube surgery.', 'eventGroups': [{'id': 'EG000', 'title': '6 mg OTO-201', 'description': '6 mg ciprofloxacin: single administration', 'otherNumAtRisk': 501, 'deathsNumAtRisk': 501, 'otherNumAffected': 200, 'seriousNumAtRisk': 501, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Upper Respiratory Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 35}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Otitis Media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Pharyngitis streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Device occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 67}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 41}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Device extrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Rhinorrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 19}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Nasal Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Ear Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 26}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numAffected': 12}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}], 'seriousEvents': [{'term': 'Influenza', 'notes': 'One of 4 adverse events that caused the subject to be hospitalized (also pneumonia, rhinovirus infection, and streptococcal infection); not related to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numEvents': 501, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects With Post-surgical Otorrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '501', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '6 mg OTO-201', 'description': '6 mg ciprofloxacin: single administration'}], 'classes': [{'categories': [{'title': 'Absence of Otorrhea', 'measurements': [{'value': '383', 'groupId': 'OG000'}]}, {'title': 'Presence of Otorrhea', 'measurements': [{'value': '118', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 4', 'description': 'Absence or presence of otorrhea (drainage from the middle ear)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set: All subjects who received study drug.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Post-surgical Otorrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '501', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '6 mg OTO-201', 'description': '6 mg ciprofloxacin: single administration'}], 'classes': [{'categories': [{'title': 'Absence of Otorrhea', 'measurements': [{'value': '334', 'groupId': 'OG000'}]}, {'title': 'Presence of Otorrhea', 'measurements': [{'value': '167', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 weeks', 'description': 'Absence or presence of otorrhea (drainage from the middle ear)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set: All subjects who received study drug'}, {'type': 'SECONDARY', 'title': 'Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '501', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '6 mg OTO-201', 'description': '6 mg ciprofloxacin: single administration'}], 'classes': [{'categories': [{'title': 'Subjects with AEs', 'measurements': [{'value': '250', 'groupId': 'OG000'}]}, {'title': 'Subjects without AEs', 'measurements': [{'value': '251', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Eight Weeks', 'description': 'Evaluation of adverse events', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set: All subjects who received study drug.'}, {'type': 'SECONDARY', 'title': 'Caregiver Burden - Ear Discharge Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '485', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '6 mg OTO-201', 'description': '6 mg ciprofloxacin: single administration'}], 'classes': [{'categories': [{'title': 'Satisfied with control of ear discharge', 'measurements': [{'value': '481', 'groupId': 'OG000'}]}, {'title': 'Not satisfied with control of ear discharge', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 4', 'description': 'Ear Drop Caregiver Burden Questionnaire at Week 4', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set: All subjects who received study drug and whose caregiver completed the questionnaire at Week 4'}, {'type': 'SECONDARY', 'title': 'Caregiver Burden - Ear Discharge Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '475', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '6 mg OTO-201', 'description': '6 mg ciprofloxacin: single administration'}], 'classes': [{'categories': [{'title': 'Satisfied with control of ear discharge', 'measurements': [{'value': '470', 'groupId': 'OG000'}]}, {'title': 'Not satisfied with control of ear discharge', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 8', 'description': 'Ear Drop Caregiver Burden Questionnaire at Week 8', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set: All subjects who received study drug, and had a completed questionnaire at Week 8'}, {'type': 'SECONDARY', 'title': 'Caregiver Burden - Ear Drops Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '6 mg OTO-201', 'description': '6 mg ciprofloxacin: single administration'}], 'classes': [{'categories': [{'title': 'Bothersome to administer ear drops', 'measurements': [{'value': '48', 'groupId': 'OG000'}]}, {'title': 'Not bothersome to administer ear drops', 'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 8', 'description': 'Ear Drop Caregiver Burden Questionnaire at Week 8', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set: All subject who received study drug, and who had to be treated with ear drops after tube placement surgery.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '6 mg OTO-201', 'description': '6 mg ciprofloxacin: single administration'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '501'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '478'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}]}]}], 'preAssignmentDetails': 'There were a total of 518 subjects screened for this study. There were 17 subjects considered screen failures, with the majority (11) failing to meet inclusion/exclusion criteria. Therefore, 501 subjects were assigned for treatment in this study and are designated as "enrolled".'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '501', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': '6 mg OTO-201', 'description': '6 mg ciprofloxacin: single administration'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '501', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'spread': '2.54', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '216', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '285', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '80', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '403', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '40', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '415', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '36', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '501', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Medicaid (Yes/No)', 'classes': [{'categories': [{'title': 'Medicaid - Yes', 'measurements': [{'value': '165', 'groupId': 'BG000'}]}, {'title': 'Medicaid - No', 'measurements': [{'value': '336', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 501}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-21', 'studyFirstSubmitDate': '2015-11-05', 'resultsFirstSubmitDate': '2020-09-01', 'studyFirstSubmitQcDate': '2015-11-05', 'lastUpdatePostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-01', 'studyFirstPostDateStruct': {'date': '2015-11-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects With Post-surgical Otorrhea', 'timeFrame': 'Week 4', 'description': 'Absence or presence of otorrhea (drainage from the middle ear)'}, {'measure': 'Number of Subjects With Post-surgical Otorrhea', 'timeFrame': '8 weeks', 'description': 'Absence or presence of otorrhea (drainage from the middle ear)'}], 'secondaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': 'Up to Eight Weeks', 'description': 'Evaluation of adverse events'}, {'measure': 'Caregiver Burden - Ear Discharge Control', 'timeFrame': 'Week 4', 'description': 'Ear Drop Caregiver Burden Questionnaire at Week 4'}, {'measure': 'Caregiver Burden - Ear Discharge Control', 'timeFrame': 'Week 8', 'description': 'Ear Drop Caregiver Burden Questionnaire at Week 8'}, {'measure': 'Caregiver Burden - Ear Drops Administration', 'timeFrame': 'Week 8', 'description': 'Ear Drop Caregiver Burden Questionnaire at Week 8'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Otitis media', 'Ear infection', 'Tympanostomy tubes'], 'conditions': ['Otitis Media']}, 'descriptionModule': {'briefSummary': 'This is an 8-week, multicenter, open-label study in which eligible subjects with a history of otitis media requiring TT placement will receive 6 mg OTO-201 to each ear. The study is designed to evaluate the safety and efficacy of OTO-201 in subjects undergoing TT placement with common concurrent surgeries and any middle ear effusion status.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria includes, but is not limited to:\n\n* Subject is a male or female aged 6 months to 17 years, inclusive\n* Subject has a history of otitis media requiring bilateral tympanostomy tube placement\n* Subject's caregiver is willing to comply with the protocol and attend all study visits\n\nExclusion Criteria includes, but is not limited to:\n\n* Subject has a history of prior ear or mastoid surgery, not including myringotomy or myringotomy with TT placement\n* Subject has been designated for any other surgical procedure that would occur concurrently with TT placement, except adenoidectomy, airway endoscopy, nasal endoscopy, and nasal cautery for epistaxis\n* Subject has a history of sensorineural hearing loss"}, 'identificationModule': {'nctId': 'NCT02600559', 'briefTitle': 'Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Otonomy, Inc.'}, 'officialTitle': 'An 8-Week, Prospective, Multicenter, Open-Label Study of OTO-201 Given as a Single Administration in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes', 'orgStudyIdInfo': {'id': '201-201507'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '0.1 mL OTO-201', 'description': 'Ciprofloxacin', 'interventionNames': ['Drug: OTO-201 (ciprofloxacin)']}], 'interventions': [{'name': 'OTO-201 (ciprofloxacin)', 'type': 'DRUG', 'otherNames': ['OTIPRIO'], 'armGroupLabels': ['0.1 mL OTO-201']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92121', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Email Otonomy Central Contact for Trial Locations', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Dean Hakanson, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Otonomy, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Otonomy, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}