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)
| Registry | NCT03196973 |
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| Status | Completed |
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| Phase | Phase 3 |
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| Study type | Interventional; randomized, parallel, masking: quadruple, treatment |
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| Enrollment | 493 (Actual) |
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| Sponsor | Salvat (Industry) |
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| Conditions | Acute Otitis Externa |
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| Interventions | DF289 plus DF277, DF289, DF277 (Drug) |
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| Dates | start 2017-07-22, primary completion 2018-08-31, completion 2018-09-14, first posted 2017-06-23, last updated 2021-04-09 |
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| Locations | 1 site in Spain |
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All trials for Acute Otitis Externa All trials of DF289 plus DF277 All trials of DF289
-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
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| DF289 plus DF277 | Experimental | Drug: DF289 plus DF277 | Otic solution |
| DF289 | Active comparator | Drug: DF289 | Otic solution |
| DF277 | Active comparator | Drug: DF277 | Otic solution |
- DF289 plus DF277 (Drug), also known as Antibiotic and Corticosteroid: 1 vial into the affected ear twice daily for 7 days
- DF289 (Drug), also known as Antibiotic: 1 vial into the affected ear twice daily for 7 days
- DF277 (Drug), also known as Corticosteroid: 1 vial into the affected ear twice daily for 7 days
+Outcome measures
Primary outcomes
- Therapeutic Cure (Clinical + Microbiological Cure) [End of Treatment (Day 8+2)]: 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 outcomes
- Time to End of Pain [From baseline to End of Study (Day 15+2)]: First day on which there is no use of analgesics, the pain score is zero and remains zero until end of study
+Eligibility
Sex: All, ages: 6 Months to any
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
+Posted results
Participant flow
| Milestone | DF289 Plus DF277 | DF289 | DF277 |
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| Started | 197 | 196 | 100 |
| Completed | 188 | 184 | 95 |
| Not completed | 9 | 12 | 5 |
Outcome results
- Therapeutic Cure (Clinical + Microbiological Cure) (Primary), Count of participants, Participants: DF289 Plus DF277 63; DF289 49; DF277 20
- Time to End of Pain (Secondary), Median, days: DF289 Plus DF277 5.0 (4.23 to 6.34); DF289 5.9 (4.26 to 7.25); DF277 7.7 (6.74 to 9.00)
Adverse events
Time frame: From study entry to Visit 4(Day 15+2)
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|
| DF289 Plus DF277 | 0/196 (0.0%) | 1/196 (0.5%) | 11/196 (5.6%) |
| DF289 | 0/195 (0.0%) | 0/195 (0.0%) | 12/195 (6.2%) |
| DF277 | 0/100 (0.0%) | 0/100 (0.0%) | 4/100 (4.0%) |
Serious adverse events by term
| Term | Organ system | DF289 Plus DF277 | DF289 | DF277 |
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| Acute Psychosis | Psychiatric disorders | 1/196 | 0/195 | 0/100 |
Other adverse events by term
| Term | Organ system | DF289 Plus DF277 | DF289 | DF277 |
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| tachycardia | Cardiac disorders | 1/196 | 0/195 | 1/100 |
| ear pain | Ear and labyrinth disorders | 2/196 | 2/195 | 0/100 |
| ear pruritus | Ear and labyrinth disorders | 0/196 | 2/195 | 0/100 |
| application site pain | General disorders | 4/196 | 0/195 | 0/100 |
| cellulitis | Infections and infestations | 0/196 | 0/195 | 1/100 |
| otitis media | Infections and infestations | 0/196 | 0/195 | 1/100 |
| back pain | Musculoskeletal and connective tissue disorders | 0/196 | 2/195 | 0/100 |
| headache | Nervous system disorders | 4/196 | 6/195 | 1/100 |
| dizziness | Nervous system disorders | 0/196 | 2/195 | 0/100 |
+Locations (1)
| Facility | City | Country | Status |
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| Laboratorios SALVAT | Esplugues de Llobregat | Spain | |
+Publications
- Results publication: 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. PMID 35834251
+Study documents
+Investigators
- Enrique Jiménez, Study director, Salvat