Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Acute Otitis Externa
NCT ID: NCT03196973
Last Updated: 2021-04-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
493 participants
INTERVENTIONAL
2017-07-22
2018-09-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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DF289 plus DF277
Otic solution
DF289 plus DF277
1 vial into the affected ear twice daily for 7 days
DF289
Otic solution
DF289
1 vial into the affected ear twice daily for 7 days
DF277
Otic solution
DF277
1 vial into the affected ear twice daily for 7 days
Interventions
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DF289 plus DF277
1 vial into the affected ear twice daily for 7 days
DF289
1 vial into the affected ear twice daily for 7 days
DF277
1 vial into the affected ear twice daily for 7 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Brighton Grading of II or III
* Culture-based diagnosis of acute bacterial otitis externa
* Willingness to refrain from swimming through end of the study
Exclusion Criteria
* Tympanic membrane perforation
* Any condition or situation likely to cause the patient to be unable or unwilling to comply with study treatment or attend all study visits
* Any condition in the patient or parent/guardian that, in the judgment of the principal investigator, could compromise patient safety, limit the patient's ability to complete the study, and/or compromise the objectives of the study
6 Months
ALL
No
Sponsors
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Salvat
INDUSTRY
Responsible Party
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Principal Investigators
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Enrique Jiménez
Role: STUDY_DIRECTOR
Salvat
Locations
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Laboratorios SALVAT
Esplugues de Llobregat, , Spain
Countries
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References
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Chu L, Acosta AM, Aazami H, Dennis P, De Valle O, Ehmer D Jr, Hedrick JA, Ansley JF. Efficacy and Safety of Ciprofloxacin Plus Fluocinolone Acetonide Among Patients With Acute Otitis Externa: A Randomized Clinical Trial. JAMA Netw Open. 2022 Jul 1;5(7):e2221699. doi: 10.1001/jamanetworkopen.2022.21699.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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DF289OT3-16IA01
Identifier Type: -
Identifier Source: org_study_id
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