Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2026-02-21 @ 2:55 PM
Study NCT ID:
NCT01908803
Status:
TERMINATED
Last Update Posted:
2017-12-06
First Post:
2013-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Proof-of-Concept Study of a Single Application of an Investigational Otic Suspension in Treatment of Acute Otitis Media With Tympanostomy Tubes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D010033', 'term': 'Otitis Media'}], 'ancestors': [{'id': 'D010031', 'term': 'Otitis'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002939', 'term': 'Ciprofloxacin'}, {'id': 'D003907', 'term': 'Dexamethasone'}], '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'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alcon.medinfo@alcon.com', 'phone': '1-888-451-3937', 'title': 'Sr Clinical Project Lead, GCRA, Pharma', 'organization': 'Alcon Research, Ltd.'}, '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 for the duration of subject participation in the study (8-10 days). AEs are reported as pre-treatment 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 patients and as observations by the Investigator as outlined in the study protocol.', 'eventGroups': [{'id': 'EG000', 'title': 'Pre-treatment', 'description': 'Includes all subjects prior to administration of study medication', 'otherNumAtRisk': 84, 'otherNumAffected': 0, 'seriousNumAtRisk': 84, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'AL-60371/AL-817', 'description': 'Includes all subjects administered a dose of AL-60371/AL-817', 'otherNumAtRisk': 44, 'otherNumAffected': 3, 'seriousNumAtRisk': 44, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'CIPRODEX', 'description': 'Includes all subjects administered a dose of CIPRODEX®', 'otherNumAtRisk': 24, 'otherNumAffected': 1, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Otitis media acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Subjects With Sustained Clinical Cure at Day 3 Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AL-60371/AL-817', 'description': '200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1)'}, {'id': 'OG001', 'title': 'CIPRODEX', 'description': 'Four drops in affected ear(s) twice daily through tympanostomy tube for 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': '38.5', 'groupId': 'OG000'}, {'value': '31.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 3 post-treatment up to Day 8 or Early Exit', 'description': 'A sustained clinical cure at Day 3 was attained if otorrhea was absent at the Day 3 visit and continued to be absent through the last study visit (Day 8 or Early Exit). Proportion of subjects is reported as a percentage.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis population includes all randomized subjects who received at least 1 dose of investigational product and were culture positive at the Day 1 visit in the study ear.'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects With Microbiological Success at the Day 8 Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AL-60371/AL-817', 'description': '200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1)'}, {'id': 'OG001', 'title': 'CIPRODEX', 'description': 'Four drops in affected ear(s) twice daily through tympanostomy tube for 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': "This outcome measure was not analyzed as a consequence of the study's early termination.", 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': "This outcome measure was not analyzed as a consequence of the study's early termination.", 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 8', 'description': 'Microbiological success was attained if all pre-therapy bacteria were absent in the Day 8 specimen. In a subject with no otorrhea at Day 8, eradication of pre-therapy bacteria was presumed and the subject was considered a microbiological success.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis population includes all randomized subjects who received at least 1 dose of investigational product and were culture positive at the Day 1 visit in the study ear.'}, {'type': 'SECONDARY', 'title': 'Median Time (in Days) to Cessation of Otorrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AL-60371/AL-817', 'description': '200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1)'}, {'id': 'OG001', 'title': 'CIPRODEX', 'description': 'Four drops in affected ear(s) twice daily through tympanostomy tube for 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': "This outcome measure was not analyzed as a consequence of the study's early termination.", 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': "This outcome measure was not analyzed as a consequence of the study's early termination.", 'groupId': 'OG001'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Time to event, up to Day 8', 'description': 'Median time (in days) to the cessation of otorrhea (ie, otorrhea was absent) was calculated as the number of days from the Day 1 (Visit 1) to the absence of otorrhea in the affected ear(s) as recorded by the parent/guardian via the twice-daily diary. Cessation of otorrhea was defined as ending on the first day that otorrhea was absent from the affected ear(s) and remained absent for any/all subsequent diary entries.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis population includes all randomized subjects who received at least 1 dose of investigational product and were culture positive at the Day 1 visit in the study ear.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AL-60371/AL-817', 'description': '200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1)'}, {'id': 'FG001', 'title': 'CIPRODEX', 'description': 'Four drops in affected ear(s) twice daily through tympanostomy tube for 7 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'Treated', 'achievements': [{'comment': 'Two randomized subjects discontinued prior to receiving investigational product.', 'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Randomization Error', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event (pre-treatment)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were recruited from 12 study centers located in the US.', 'preAssignmentDetails': 'Of the 84 enrolled, 14 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (70).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'AL-60371/AL-817', 'description': '200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1)'}, {'id': 'BG001', 'title': 'CIPRODEX', 'description': 'Four drops in affected ear(s) twice daily through tympanostomy tube for 7 days'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'spread': '2.60', 'groupId': 'BG000'}, {'value': '2.4', 'spread': '1.54', 'groupId': 'BG001'}, {'value': '2.7', 'spread': '2.28', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'This analysis population includes all randomized and treated subjects.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'whyStopped': 'Management decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-02', 'studyFirstSubmitDate': '2013-07-24', 'resultsFirstSubmitDate': '2015-08-24', 'studyFirstSubmitQcDate': '2013-07-25', 'lastUpdatePostDateStruct': {'date': '2017-12-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-08-24', 'studyFirstPostDateStruct': {'date': '2013-07-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Subjects With Sustained Clinical Cure at Day 3 Visit', 'timeFrame': 'Day 3 post-treatment up to Day 8 or Early Exit', 'description': 'A sustained clinical cure at Day 3 was attained if otorrhea was absent at the Day 3 visit and continued to be absent through the last study visit (Day 8 or Early Exit). Proportion of subjects is reported as a percentage.'}], 'secondaryOutcomes': [{'measure': 'Proportion of Subjects With Microbiological Success at the Day 8 Visit', 'timeFrame': 'Day 8', 'description': 'Microbiological success was attained if all pre-therapy bacteria were absent in the Day 8 specimen. In a subject with no otorrhea at Day 8, eradication of pre-therapy bacteria was presumed and the subject was considered a microbiological success.'}, {'measure': 'Median Time (in Days) to Cessation of Otorrhea', 'timeFrame': 'Time to event, up to Day 8', 'description': 'Median time (in days) to the cessation of otorrhea (ie, otorrhea was absent) was calculated as the number of days from the Day 1 (Visit 1) to the absence of otorrhea in the affected ear(s) as recorded by the parent/guardian via the twice-daily diary. Cessation of otorrhea was defined as ending on the first day that otorrhea was absent from the affected ear(s) and remained absent for any/all subsequent diary entries.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['AOMT', 'tympanostomy tubes', 'Otorrhea', 'anti-infective'], 'conditions': ['Acute Otitis Media']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate a single application of AL-60371/AL-817 Otic Suspension relative to ototopical CIPRODEX for sustained clinical cure, microbiological success, and time to cessation of otorrhea.', 'detailedDescription': 'The results at the time of the interim analysis met the futility criteria and the study was subsequently stopped.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parent or guardian: Read and sign the informed consent. When required by the Institutional Review Board, child must agree to sign an approved assent form;\n* Presence of otorrhea (visible by parent or guardian) of 21 days or less in duration;\n* Presence of patent tympanostomy tubes;\n* 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* Parent or guardian: Agree to comply with the requirements of the study, administer the study medication as directed, complete required study visits, and comply with the protocol;\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* NOT otorrhea-free for at least seven days following tympanostomy tube surgery;\n* Menarcheal females;\n* Previous otologic surgery, except tympanic membrane, within one year of study entry;\n* History of/or current acute or chronic non-tube otorrhea (through existing perforation of the eardrum);\n* Current acute otitis externa, malignant otitis externa, or other conditions which could interfere with evaluation of the study drug;\n* Diabetic (controlled or uncontrolled);\n* Use of prohibited medications;\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01908803', 'briefTitle': 'Proof-of-Concept Study of a Single Application of an Investigational Otic Suspension in Treatment of Acute Otitis Media With Tympanostomy Tubes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Proof of Concept of Single Application of AL-60371/AL-817 Otic Suspension in Treatment of Acute Otitis Media With Tympanostomy Tubes Compared to CIPRODEX® (BID for 7 Days)', 'orgStudyIdInfo': {'id': 'C-13-026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AL-60371/AL-817', 'description': 'AL-60371/AL-817 otic suspension, 200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1)', 'interventionNames': ['Drug: AL-60371/AL-817 otic suspension']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CIPRODEX', 'description': 'Ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension, 4 drops in affected ear(s) twice daily through tympanostomy tube for 7 days', 'interventionNames': ['Drug: Ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension']}], 'interventions': [{'name': 'AL-60371/AL-817 otic suspension', 'type': 'DRUG', 'armGroupLabels': ['AL-60371/AL-817']}, {'name': 'Ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension', 'type': 'DRUG', 'description': 'CIPRODEX®', 'armGroupLabels': ['CIPRODEX']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Clinical Manager, GCRA, Pharma', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}