Back to resultsEfficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Acute Otitis Externa
Primary Purpose
Acute Otitis Externa
Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
DF289 plus DF277
DF289
DF277
Sponsored by
About this trial
This is an interventional treatment trial for Acute Otitis Externa
Eligibility Criteria
Inclusion Criteria:
- Uncomplicated AOE of less tan 21 days, defined as a total symptom score of at least 2 for otalgia, 2 for edema and 1 for otorrhea
- 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:
- Previous episode of AOE within 4 weeks prior to enrollment, or 2 or more episodes of AOE within 6 months prior to the enrollment.
- 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
Sites / Locations
- Laboratorios SALVAT
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
DF289 plus DF277
DF289
DF277
Arm Description
Otic solution
Otic solution
Otic solution
Outcomes
Primary Outcome Measures
Therapeutic Cure (Clinical + Microbiological Cure)
Therapeutic cure will be considered achieved if edema, otalgia and otorrhea are resolved with no further requirement of antimicrobial therapy and bacteriological response is Eradication or Presumed Eradication
Secondary Outcome Measures
Time to End of Pain
First day on which there is no use of analgesics, the pain score is zero and remains zero until end of study
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03196973
Brief Title
Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Acute Otitis Externa
Official Title
A Phase III, Multicenter, Randomized, Double-Blind Clinical Trial to Assess the Efficacy and Safety of DF289 Plus DF277 Otic Solution Compared to DF289 Otic Solution and to DF277 Otic Solution in the Treatment of Acute Otitis Externa (AOE)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
July 22, 2017 (Actual)
Primary Completion Date
August 31, 2018 (Actual)
Study Completion Date
September 14, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Salvat
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine if a combination of an antibiotic plus a corticosteroid is safe and effective in treating AOE
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Otitis Externa
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
493 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DF289 plus DF277
Arm Type
Experimental
Arm Description
Otic solution
Arm Title
DF289
Arm Type
Active Comparator
Arm Description
Otic solution
Arm Title
DF277
Arm Type
Active Comparator
Arm Description
Otic solution
Intervention Type
Drug
Intervention Name(s)
DF289 plus DF277
Other Intervention Name(s)
Antibiotic and Corticosteroid
Intervention Description
1 vial into the affected ear twice daily for 7 days
Intervention Type
Drug
Intervention Name(s)
DF289
Other Intervention Name(s)
Antibiotic
Intervention Description
1 vial into the affected ear twice daily for 7 days
Intervention Type
Drug
Intervention Name(s)
DF277
Other Intervention Name(s)
Corticosteroid
Intervention Description
1 vial into the affected ear twice daily for 7 days
Primary Outcome Measure Information:
Title
Therapeutic Cure (Clinical + Microbiological Cure)
Description
Therapeutic cure will be considered achieved if edema, otalgia and otorrhea are resolved with no further requirement of antimicrobial therapy and bacteriological response is Eradication or Presumed Eradication
Time Frame
End of Treatment (Day 8+2)
Secondary Outcome Measure Information:
Title
Time to End of Pain
Description
First day on which there is no use of analgesics, the pain score is zero and remains zero until end of study
Time Frame
From baseline to End of Study (Day 15+2)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Uncomplicated AOE of less tan 21 days, defined as a total symptom score of at least 2 for otalgia, 2 for edema and 1 for otorrhea
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:
Previous episode of AOE within 4 weeks prior to enrollment, or 2 or more episodes of AOE within 6 months prior to the enrollment.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enrique Jiménez
Organizational Affiliation
Salvat
Official's Role
Study Director
Facility Information:
Facility Name
Laboratorios SALVAT
City
Esplugues de Llobregat
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
35834251
Citation
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.
Results Reference
derived
Learn more about this trial
Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Acute Otitis Externa
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