Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2026-01-01 @ 6:52 PM
Study NCT ID:
NCT02436304
Status:
COMPLETED
Last Update Posted:
2018-07-02
First Post:
2015-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of EXE844 Otic Suspension in Otitis Media at Time of Tympanostomy Tube Insertion (OMTT) - Study 2
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'interventionBrowseModule': {'meshes': [{'id': 'D008876', 'term': 'Middle Ear Ventilation'}], 'ancestors': [{'id': 'D010030', 'term': 'Ostomy'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013506', 'term': 'Otologic Surgical Procedures'}, {'id': 'D013517', 'term': 'Otorhinolaryngologic Surgical Procedures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alcon.medinfo@alcon.com', 'phone': '1-888-451-3937', 'title': 'Clinical Scientific Director, GCRA', 'organization': 'Alcon, A Novartis Division'}, 'certainAgreement': {'otherDetails': 'Sponsor reserves the right of prior review of any publication or presentation of information related to the study.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': "Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 28 days). AEs are reported as pretreatment and treatment-emergent.", 'description': 'An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained as solicited comments from the study participants and as observations by the Investigator as outlined in the study protocol.', 'eventGroups': [{'id': 'EG000', 'title': 'Pretreatment', 'description': 'All who consented to participate in the study prior to randomization', 'otherNumAtRisk': 404, 'deathsNumAtRisk': 404, 'otherNumAffected': 2, 'seriousNumAtRisk': 404, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'EXE844 7 Days', 'description': 'All participants exposed to EXE844 Sterile Otic Suspension, 0.3% for 7 days after Tympanostomy Tube Insertion', 'otherNumAtRisk': 153, 'deathsNumAtRisk': 153, 'otherNumAffected': 39, 'seriousNumAtRisk': 153, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'EXE844 3 Days', 'description': 'All participants exposed to EXE844 Sterile Otic Suspension, 0.3%, for 3 days after Tympanostomy Tube Insertion', 'otherNumAtRisk': 102, 'deathsNumAtRisk': 102, 'otherNumAffected': 19, 'seriousNumAtRisk': 102, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Tubes Only', 'description': 'All participants who underwent bilateral myringotomy and tympanostomy tube insertion only', 'otherNumAtRisk': 101, 'deathsNumAtRisk': 101, 'otherNumAffected': 13, 'seriousNumAtRisk': 101, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Ear Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 5}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 404, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 102, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 101, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects With Sustained Clinical Cure at Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'EXE844 7 Days', 'description': 'EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops, BID in each ear for 7 days after Tympanostomy Tube Insertion'}, {'id': 'OG001', 'title': 'EXE844 3 Days', 'description': 'EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion'}, {'id': 'OG002', 'title': 'Tubes Only', 'description': 'Bilateral myringotomy and tympanostomy tube insertion'}], 'classes': [{'categories': [{'measurements': [{'value': '77.1', 'groupId': 'OG000'}, {'value': '75.5', 'groupId': 'OG001'}, {'value': '65.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 8', 'description': 'Sustained clinical cure was defined as the absence of otorrhea in the study ear at Day 8 (end of treatment (EOT)) per the Investigator assessment. Participants were considered a treatment failure if, at any time during the course of the study, an alternative therapy was initiated to treat the post-surgical infection. All participants who had missing or indeterminate outcomes were considered a failure (same as baseline observation carried forward).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Microbiological Success at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'EXE844 7 Days', 'description': 'EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops, BID in each ear for 7 days after Tympanostomy Tube Insertion'}, {'id': 'OG001', 'title': 'EXE844 3 Days', 'description': 'EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion'}, {'id': 'OG002', 'title': 'Tubes Only', 'description': 'Bilateral myringotomy and tympanostomy tube insertion'}], 'classes': [{'categories': [{'measurements': [{'value': '72.5', 'groupId': 'OG000'}, {'value': '69.0', 'groupId': 'OG001'}, {'value': '51.9', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 14', 'description': 'Microbiological success was attained if all pretherapy bacteria were absent in the study ear for the test-of-cure (TOC) specimen, which was presumed a success for subjects with no otorrhea at Day 14. Participants were considered a treatment failure if, at any time during the course of the study, an alternative therapy was initiated to treat the post-surgical infection. All participants who had missing or indeterminate outcomes were considered a failure (same as baseline observation carried forward).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis population includes all ITT participants who were culture-positive at Day 1 in at least 1 ear (Microbiological Intent-to-Treat (MITT) analysis set)'}, {'type': 'SECONDARY', 'title': 'Time to Cessation of Otorrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'EXE844 7 Days', 'description': 'EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops, BID in each ear for 7 days after Tympanostomy Tube Insertion'}, {'id': 'OG001', 'title': 'EXE844 3 Days', 'description': 'EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion'}, {'id': 'OG002', 'title': 'Tubes Only', 'description': 'Bilateral myringotomy and tympanostomy tube insertion'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '3.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '3.0'}, {'value': '1.5', 'groupId': 'OG002', 'lowerLimit': '0.5', 'upperLimit': '3.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Day 14', 'description': 'The time to cessation of otorrhea in the enrolled ear(s) was calculated as the number of days from the day of surgery to the absence of otorrhea (ie, no discharge) as reported by the parent/caregiver. Participants were considered a treatment failure if, at any time during the course of the study, an alternative therapy was initiated to treat the post-surgical infection. All participants who had missing or indeterminate outcomes were considered a failure (same as baseline observation carried forward).', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'EXE844 7 Days', 'description': 'EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops, twice daily (BID) in each ear for 7 days after Tympanostomy Tube Insertion'}, {'id': 'FG001', 'title': 'EXE844 3 Days', 'description': 'EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion'}, {'id': 'FG002', 'title': 'Tubes Only', 'description': 'Bilateral myringotomy and tympanostomy tube insertion'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '153'}, {'groupId': 'FG001', 'numSubjects': '102'}, {'groupId': 'FG002', 'numSubjects': '101'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '153'}, {'groupId': 'FG001', 'numSubjects': '100'}, {'groupId': 'FG002', 'numSubjects': '100'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': "Randomized in error didn't meet I/E crit", 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were recruited from 19 study centers located in Canada (3) and the US (16).', 'preAssignmentDetails': 'Of the 404 enrolled, 48 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants (356).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}, {'value': '356', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'EXE844 7 Days', 'description': 'EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops, BID in each ear for 7 days after Tympanostomy Tube Insertion'}, {'id': 'BG001', 'title': 'EXE844 3 Days', 'description': 'EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion'}, {'id': 'BG002', 'title': 'Tubes Only', 'description': 'Bilateral myringotomy and tympanostomy tube insertion'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'spread': '2.05', 'groupId': 'BG000'}, {'value': '2.8', 'spread': '2.31', 'groupId': 'BG001'}, {'value': '2.6', 'spread': '2.31', 'groupId': 'BG002'}, {'value': '2.5', 'spread': '2.20', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '136', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '220', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'This analysis population includes all randomized participants, including those who underwent concurrent adenoidectomy and/or tonsillectomy (Intent-to-treat (ITT) analysis set)'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 404}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2016-08-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-31', 'studyFirstSubmitDate': '2015-05-04', 'resultsFirstSubmitDate': '2017-07-28', 'studyFirstSubmitQcDate': '2015-05-04', 'lastUpdatePostDateStruct': {'date': '2018-07-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-07-28', 'studyFirstPostDateStruct': {'date': '2015-05-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects With Sustained Clinical Cure at Day 8', 'timeFrame': 'Day 8', 'description': 'Sustained clinical cure was defined as the absence of otorrhea in the study ear at Day 8 (end of treatment (EOT)) per the Investigator assessment. Participants were considered a treatment failure if, at any time during the course of the study, an alternative therapy was initiated to treat the post-surgical infection. All participants who had missing or indeterminate outcomes were considered a failure (same as baseline observation carried forward).'}], 'secondaryOutcomes': [{'measure': 'Percentage of Subjects With Microbiological Success at Day 14', 'timeFrame': 'Day 14', 'description': 'Microbiological success was attained if all pretherapy bacteria were absent in the study ear for the test-of-cure (TOC) specimen, which was presumed a success for subjects with no otorrhea at Day 14. Participants were considered a treatment failure if, at any time during the course of the study, an alternative therapy was initiated to treat the post-surgical infection. All participants who had missing or indeterminate outcomes were considered a failure (same as baseline observation carried forward).'}, {'measure': 'Time to Cessation of Otorrhea', 'timeFrame': 'Up to Day 14', 'description': 'The time to cessation of otorrhea in the enrolled ear(s) was calculated as the number of days from the day of surgery to the absence of otorrhea (ie, no discharge) as reported by the parent/caregiver. Participants were considered a treatment failure if, at any time during the course of the study, an alternative therapy was initiated to treat the post-surgical infection. All participants who had missing or indeterminate outcomes were considered a failure (same as baseline observation carried forward).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Otitis Media With Effusion in Children', 'Otitis Media Recurrent']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate EXE844 plus tympanostomy tubes compared to tympanostomy tubes only based on sustained clinical cure at end-of-therapy (EOT).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recurrent acute otitis media (RAOM) or chronic otitis media with effusion (COME) and eligible for bilateral myringotomy and tympanostomy tube insertion.\n* Suspected bacterial infection at time of surgery in at least 1 ear.\n* Willing to refrain from water immersion of the ears following surgery without the use of adequate ear protection during swimming, bathing, showering and other water-related activities.\n* Legally Authorized Representative (LAR) must read and sign the informed consent.\n* Parent or caregiver must agree to comply with the requirements of the study and administer study medication as directed, complete required study visits, and comply with the protocol.\n* Other protocol-specified inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Previous otologic or otologic-related surgery within the past 30 days or ongoing complications.\n* Middle ear pathology in either ear other than otitis media.\n* Current acute otitis externa (AOE), malignant otitis externa (MOE) or other conditions which could interfere with evaluation of the study drug.\n* Any systemic disease or disorder, complicating factor or structural abnormality that would negatively affect the conduct or outcome of the study based upon assessment by the Investigator.\n* Known or suspected allergy or hypersensitivity to quinolones or other active or inactive ingredients present in the medications to be used in the study.\n* Other protocol-specified exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT02436304', 'briefTitle': 'Safety and Efficacy of EXE844 Otic Suspension in Otitis Media at Time of Tympanostomy Tube Insertion (OMTT) - Study 2', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Safety and Efficacy of EXE844 Otic Suspension in the Treatment of Otitis Media at Time of Tympanostomy Tube Insertion', 'orgStudyIdInfo': {'id': 'EXE844b-C002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EXE844 for 7 Days + Tubes', 'description': 'EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops, twice daily (BID) in each ear for 7 days after Tympanostomy Tube Insertion', 'interventionNames': ['Drug: EXE844 Sterile Otic Suspension, 0.3%', 'Procedure: Tympanostomy Tube Insertion']}, {'type': 'EXPERIMENTAL', 'label': 'EXE844 for 3 Days + Tubes', 'description': 'EXE844 Sterile Otic Suspension, 0.3%, ototopical, 4 drops BID in each ear for 3 days after Tympanostomy Tube Insertion', 'interventionNames': ['Drug: EXE844 Sterile Otic Suspension, 0.3%', 'Procedure: Tympanostomy Tube Insertion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tubes Only', 'description': 'Bilateral myringotomy and tympanostomy tube insertion', 'interventionNames': ['Procedure: Tympanostomy Tube Insertion']}], 'interventions': [{'name': 'EXE844 Sterile Otic Suspension, 0.3%', 'type': 'DRUG', 'armGroupLabels': ['EXE844 for 3 Days + Tubes', 'EXE844 for 7 Days + Tubes']}, {'name': 'Tympanostomy Tube Insertion', 'type': 'PROCEDURE', 'description': 'Surgical procedure for treating pediatric cases of recurrent or chronic otitis media', 'armGroupLabels': ['EXE844 for 3 Days + Tubes', 'EXE844 for 7 Days + Tubes', 'Tubes Only']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Clinical Manager, Ophtha-GCRA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon, A Novartis Division'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}