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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DF289 plus DF277 | Experimental | Otic solution |
|
| DF289 | Active Comparator | Otic solution |
|
| DF277 | Active Comparator | Otic solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DF289 plus DF277 | Drug | 1 vial into the affected ear twice daily for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | End of Treatment (Day 8+2) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From baseline to End of Study (Day 15+2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Enrique Jiménez | Salvat | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratorios SALVAT | Esplugues de Llobregat | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35834251 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | DF289 Plus DF277 | Otic solution DF289 plus DF277: 1 vial into the affected ear twice daily for 7 days |
| FG001 | DF289 | Otic solution DF289: 1 vial into the affected ear twice daily for 7 days |
| FG002 | DF277 | Otic solution DF277: 1 vial into the affected ear twice daily for 7 days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
CITT Population (Randomized patients)
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| ID | Title | Description |
|---|---|---|
| BG000 | DF289 Plus DF277 | Otic solution DF289 plus DF277: 1 vial into the affected ear twice daily for 7 days |
| BG001 | DF289 | Otic solution DF289: 1 vial into the affected ear twice daily for 7 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Randomized patients with positive culture for pathogens at baseline | Posted | Count of Participants | Participants | End of Treatment (Day 8+2) |
|
From study entry to Visit 4(Day 15+2)
Related and unrelated adverse events are reported which frequency was 1% or more in one of the arms.
2 subjects (1 from the DF289Plus DF277 arm and 1 from the DF289) are excluded from the safety population because they did not receive any dose of study medication.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DF289 Plus DF277 | Otic solution DF289 plus DF277: 1 vial into the affected ear twice daily for 7 days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Psychosis | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment | The SAE was not related to the study medication |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| tachycardia | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Laboratorios Salvat, S.A. | 933946400 | ejimenez@svt.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 26, 2018 | Nov 17, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 14, 2018 | Dec 14, 2020 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D000900 | Anti-Bacterial Agents |
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| DF289 | Drug | 1 vial into the affected ear twice daily for 7 days |
|
|
| DF277 | Drug | 1 vial into the affected ear twice daily for 7 days |
|
|
| Lost to Follow-up |
|
| Consent withdrawn |
|
| Administration of a wrong kit of study medication |
|
| BG002 | DF277 | Otic solution DF277: 1 vial into the affected ear twice daily for 7 days |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | DF277 | Otic solution DF277: 1 vial into the affected ear twice daily for 7 days |
|
|
| Secondary | 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 | Randomized patients with positive culture for pathogens at baseline | Posted | Median | 95% Confidence Interval | days | From baseline to End of Study (Day 15+2) |
|
|
|
| 0 |
| 196 |
| 1 |
| 196 |
| 11 |
| 196 |
| EG001 | DF289 | Otic solution DF289: 1 vial into the affected ear twice daily for 7 days | 0 | 195 | 0 | 195 | 12 | 195 |
| EG002 | DF277 | Otic solution DF277: 1 vial into the affected ear twice daily for 7 days | 0 | 100 | 0 | 100 | 4 | 100 |
|
| ear pain | Ear and labyrinth disorders | MedDRA (20.0) | Systematic Assessment |
|
| ear pruritus | Ear and labyrinth disorders | MedDRA (20.0) | Systematic Assessment |
|
| application site pain | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| cellulitis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| otitis media | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| back pain | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| headache | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| dizziness | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
Any publication by PI of the Study Results shall not be made before the first multi-center publication.
PI shall allow Sponsor not less than 60 days to review any manuscript and not less than 30 days to review any other documentation which describes or discloses the Study Results. Sponsor can request an additional 60 days.
Sponsor reserves the right to remove all Confidential Information from any publications or presentations.
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |