Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-31 @ 10:45 AM
Study NCT ID:
NCT01395966
Status:
COMPLETED
Last Update Posted:
2015-10-22
First Post:
2011-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Study to Assess the Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Middle Ear Infections in Pediatric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010033', 'term': 'Otitis Media'}], 'ancestors': [{'id': 'D010031', 'term': 'Otitis'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ejimenezv@salvatbiotech.com', 'phone': '+34933946470', 'title': 'Enrique Jimenez, Medical Director', 'organization': 'Laboratorios SALVAT'}, 'certainAgreement': {'otherDetails': 'Sponsor does not object to publication by Institution of the results of the Trial based on information collected or generated by Institution, whether or not the results are favorable to the Sponsor Drug. However, to ensure against inadvertent disclosure of Confidential Information or unprotected Inventions, Institution will provide Sponsor an opportunity to review any proposed publication or other type of disclosure before it is submitted or otherwise disclosed.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'During all the study (22 days)', 'description': 'Only related TEAE are reported. There were 331 patients randomized, but only 327 were dosed. Only dosed patients are considered for the AE Reporting.\n\nOne patient was randomized to receive DF277 but began taking DF289 Plus DF277. This patient is included in the safety population under DF289 Plus DF277 treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'DF289', 'description': 'Ear drops\n\nDF289: Ear drops', 'otherNumAtRisk': 108, 'otherNumAffected': 4, 'seriousNumAtRisk': 108, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'DF277', 'description': 'Ear drops\n\nDF277: Ear drops', 'otherNumAtRisk': 106, 'otherNumAffected': 9, 'seriousNumAtRisk': 106, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'DF289 Plus DF277', 'description': 'Ear drops\n\nDF289 plus DF277: Ear drops', 'otherNumAtRisk': 113, 'otherNumAffected': 7, 'seriousNumAtRisk': 113, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'auricular swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 13.0'}, {'term': 'ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 13.0'}, {'term': 'otorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 13.0'}, {'term': 'ear canal erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 13.0'}, {'term': 'ear discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 13.0'}, {'term': 'ear haemorrahage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 13.0'}, {'term': 'otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 13.0'}, {'term': 'otitis media acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 13.0'}, {'term': 'ear infection fungal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 13.0'}, {'term': 'otitis externa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 13.0'}, {'term': 'excessive granulation tissue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 13.0'}, {'term': 'rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 13.0'}, {'term': 'dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 13.0'}, {'term': 'eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 13.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Cessation of Otorrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DF289', 'description': 'Ear drops\n\nDF289: Ear drops'}, {'id': 'OG001', 'title': 'DF277', 'description': 'Ear drops\n\nDF277: Ear drops'}, {'id': 'OG002', 'title': 'DF289 Plus DF277', 'description': 'Ear drops\n\nDF289 plus DF277: Ear drops'}], 'classes': [{'categories': [{'measurements': [{'value': '7.69', 'groupId': 'OG000', 'lowerLimit': '4.78', 'upperLimit': '11.44'}, {'value': '22', 'groupId': 'OG001', 'lowerLimit': '7.43', 'upperLimit': '22'}, {'value': '3.75', 'groupId': 'OG002', 'lowerLimit': '3.04', 'upperLimit': '4.39'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From baseline until the end of the study ( up to 22 days)', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DF289', 'description': 'Ear drops\n\nDF289: Ear drops'}, {'id': 'FG001', 'title': 'DF277', 'description': 'Ear drops\n\nDF277: Ear drops'}, {'id': 'FG002', 'title': 'DF289 Plus DF277', 'description': 'Ear drops\n\nDF289 plus DF277: Ear drops'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '109'}, {'groupId': 'FG001', 'numSubjects': '110'}, {'groupId': 'FG002', 'numSubjects': '112'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}, {'groupId': 'FG001', 'numSubjects': '91'}, {'groupId': 'FG002', 'numSubjects': '104'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '8'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}, {'value': '331', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'DF289', 'description': 'Ear drops\n\nDF289: Ear drops'}, {'id': 'BG001', 'title': 'DF277', 'description': 'Ear drops\n\nDF277: Ear drops'}, {'id': 'BG002', 'title': 'DF289 Plus DF277', 'description': 'Ear drops\n\nDF289 plus DF277: Ear drops'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}, {'value': '331', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'spread': '2.7', 'groupId': 'BG000'}, {'value': '3.5', 'spread': '2.6', 'groupId': 'BG001'}, {'value': '3.2', 'spread': '2.5', 'groupId': 'BG002'}, {'value': '3.4', 'spread': '2.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '198', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '133', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 331}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-22', 'studyFirstSubmitDate': '2011-07-08', 'resultsFirstSubmitDate': '2015-07-22', 'studyFirstSubmitQcDate': '2011-07-14', 'lastUpdatePostDateStruct': {'date': '2015-10-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-09-22', 'studyFirstPostDateStruct': {'date': '2011-07-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Cessation of Otorrhea', 'timeFrame': 'From baseline until the end of the study ( up to 22 days)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['with tubes'], 'conditions': ['Acute Otitis Media']}, 'referencesModule': {'references': [{'pmid': '28006041', 'type': 'DERIVED', 'citation': 'Spektor Z, Pumarola F, Ismail K, Lanier B, Hussain I, Ansley J, Butehorn HF 3rd, Esterhuizen K, Byers J, Douglis F, Lansford B, Hernandez FJ. Efficacy and Safety of Ciprofloxacin Plus Fluocinolone in Otitis Media With Tympanostomy Tubes in Pediatric Patients: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2017 Apr 1;143(4):341-349. doi: 10.1001/jamaoto.2016.3537.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if the combination of DF289 plus DF277 is safe and effective in treating middle ear infections in children with ear tubes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 6 months to 12 years\n* ear tube in the ear which will be treated\n* otorrhea for 3 weeks or less\n* moderate or severe otorrhea\n\nExclusion Criteria:\n\n* other ear diseases'}, 'identificationModule': {'nctId': 'NCT01395966', 'briefTitle': 'Clinical Study to Assess the Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Middle Ear Infections in Pediatric Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Salvat'}, 'officialTitle': 'Clinical Study to Assess the Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Middle Ear Infections in Pediatric Patients', 'orgStudyIdInfo': {'id': 'DF289III/10IA02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'DF289', 'description': 'Ear drops', 'interventionNames': ['Drug: DF289']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'DF277', 'description': 'Ear drops', 'interventionNames': ['Drug: DF277']}, {'type': 'EXPERIMENTAL', 'label': 'DF289 plus DF277', 'description': 'Ear drops', 'interventionNames': ['Drug: DF289 plus DF277']}], 'interventions': [{'name': 'DF289', 'type': 'DRUG', 'description': 'Ear drops', 'armGroupLabels': ['DF289']}, {'name': 'DF277', 'type': 'DRUG', 'description': 'Ear drops', 'armGroupLabels': ['DF277']}, {'name': 'DF289 plus DF277', 'type': 'DRUG', 'description': 'Ear drops', 'armGroupLabels': ['DF289 plus DF277']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08950', 'city': 'Esplugues de Llobregat', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Laboratorios Salvat, S.A.', 'geoPoint': {'lat': 41.37732, 'lon': 2.08809}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Salvat', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}