Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine if the combination of DF289 plus DF277 is safe and effective in treating middle ear infections in children with ear tubes.
Not provided
Not provided
Not provided
Not provided
Not provided
| 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) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|
Not provided
Not provided
| 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)
Only related TEAE are reported. There were 331 patients randomized, but only 327 were dosed. Only dosed patients are considered for the AE Reporting.
One patient was randomized to receive DF277 but began taking DF289 Plus DF277. This patient is included in the safety population under DF289 Plus DF277 treatment.
Not provided
| 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 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| auricular swelling | Ear and labyrinth disorders | MedRA 13.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Enrique Jimenez, Medical Director | Laboratorios SALVAT | +34933946470 | ejimenezv@salvatbiotech.com |
Not provided
| ID | Term |
|---|---|
| D010033 | Otitis Media |
| ID | Term |
|---|---|
| D010031 | Otitis |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|
|
| 0 |
| 108 |
| 4 |
| 108 |
| EG001 | DF277 | Ear drops DF277: Ear drops | 0 | 106 | 9 | 106 |
| EG002 | DF289 Plus DF277 | Ear drops DF289 plus DF277: Ear drops | 0 | 113 | 7 | 113 |
| ear pain | Ear and labyrinth disorders | MedRA 13.0 | Systematic Assessment |
|
| otorrhoea | Ear and labyrinth disorders | MedRA 13.0 | Systematic Assessment |
|
| ear canal erythema | Ear and labyrinth disorders | MedRA 13.0 | Systematic Assessment |
|
| ear discomfort | Ear and labyrinth disorders | MedRA 13.0 | Systematic Assessment |
|
| ear haemorrahage | Ear and labyrinth disorders | MedRA 13.0 | Systematic Assessment |
|
| otitis media | Infections and infestations | MedRA 13.0 | Systematic Assessment |
|
| otitis media acute | Infections and infestations | MedRA 13.0 | Systematic Assessment |
|
| ear infection fungal | Infections and infestations | MedRA 13.0 | Systematic Assessment |
|
| otitis externa | Infections and infestations | MedRA 13.0 | Systematic Assessment |
|
| excessive granulation tissue | Skin and subcutaneous tissue disorders | MedRA 13.0 | Systematic Assessment |
|
| rash | Infections and infestations | MedRA 13.0 | Systematic Assessment |
|
| dermatitis | Skin and subcutaneous tissue disorders | MedRA 13.0 | Systematic Assessment |
|
| eczema | Skin and subcutaneous tissue disorders | MedRA 13.0 | Systematic Assessment |
|
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.