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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 middle ear infections in children with ear tubes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DF289 | Active Comparator | Ear drops |
|
| DF277 | Active Comparator | Ear drops |
|
| DF289 plus DF277 | Experimental | Ear drops |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DF289 | Drug | Ear drops |
| |
| DF277 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Cessation of Otorrhea | From baseline until the end of the study (up to 22 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratorios SALVAT S.A. | Esplugues de Llobregat | Barcelona | 08950 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28006041 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | DF289 | Ear drops DF289: Ear drops |
| FG001 | DF277 | Ear drops DF277: Ear drops |
| FG002 | DF289 Plus DF277 | Ear drops DF289 plus DF277: Ear drops |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | DF289 | Ear drops DF289: Ear drops |
| BG001 | DF277 | Ear drops DF277: Ear drops |
| 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 | Time to Cessation of Otorrhea | Posted | Median | 95% Confidence Interval | days | From baseline until the end of the study (up to 22 days) |
|
During all the study (22 days)
There were 331 patients randomized in the study, but only 330 patients were dosed. Only dosed patients are considered for the Adverse Event Reporting.
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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 | Ear drops DF289: Ear drops |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mastoiditis | Infections and infestations | MedDRA 13.0 | Systematic Assessment | Non related TEAE |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment | Non related TEAE |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Enrique Jimenez, Medical Director | Laboratorios SALVAT | +34933946470 | ejimenezv@salvatbiotech.com |
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| ID | Term |
|---|---|
| D010033 | Otitis Media |
| ID | Term |
|---|---|
| D010031 | Otitis |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| Drug |
Ear drops |
|
| DF289 plus DF277 | Drug | Ear drops |
|
| BG002 |
| DF289 Plus DF277 |
Ear drops DF289 plus DF277: Ear drops |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| 1 |
| 112 |
| 20 |
| 112 |
| EG001 | DF277 | Ear drops DF277: Ear drops | 0 | 107 | 29 | 107 |
| EG002 | DF289 Plus DF277 | Ear drops DF289 plus DF277: Ear drops | 1 | 111 | 25 | 111 |
|
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment | Non related TEAE |
|
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment | Non related TEAE |
|
| Nasopharyngitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment | Non related TEAE |
|
| Otorrhoea | Ear and labyrinth disorders | MedDRA 13.0 | Systematic Assessment | Only 1 event in the DF289 group and 2 events in the DF277 group were considered related TEAE. The other events were considered non related TEAE |
|
| Pyrexia | General disorders | MedDRA 13.0 | Systematic Assessment | Non related TEAE |
|
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.