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This is a 1-month, prospective, multicenter, open-label study in pediatric subjects with either unilateral or bilateral acute otitis media with tympanostomy tubes (AOMT). Eligible subjects will receive a single dose of 6 mg OTO-201 to the affected ear(s). The study is designed to characterize safety, procedural factors and clinical effect of OTO-201 administered in subjects with AOMT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OTO-201 | Experimental | 6 mg OTO-201 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OTO-201 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Ears With Otorrhea (Drainage From the Middle Ear) | Acute otitis media with tympanostomy tubes in place (AOMT) refers to subjects that have ear tubes present, but have a middle ear infection. Otorrhea is fluid drainage from the middle ear. This outcome is assessed during the otoscopic examination of each affected ear (the ear with the infection). All subjects have otorrhea in the affected ear at Baseline and the assessment is done after administering OTO-201 to be sure there is no infection remaining or no new infection. | Day 29 |
| Feasibility of Administration Questionnaire | Issues Administering OTO-201 onto the Tympanic Membrane and the Auditory Canal-facing Side of the Tympanostomy Tube (answered "yes") | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Ears With no More Otorrhea (Drainage From the Middle Ear) | Acute otitis media with tympanostomy tubes in place (AOMT) refers to subjects that have ear tubes present, but have a middle ear infection. Otorrhea is fluid drainage from the middle ear. This outcome is assessed during the otoscopic examination of each affected ear (the ear with the infection). All subjects have otorrhea in the affected ear at Baseline and the assessment is done 15 days after administering OTO-201 to see if it worked and there is no more drainage from the middle ear. |
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Inclusion Criteria includes, but is not limited to:
Exclusion Criteria includes, but is not limited to:
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| Name | Affiliation | Role |
|---|---|---|
| Carl LeBel, PhD | Otonomy, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central California Ear, Nose and Throat | Fresno | California | United States | |||
| South Florida Pediatric Otolaryngology |
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| ID | Title | Description |
|---|---|---|
| FG000 | OTO-201 | 6 mg OTO-201 OTO-201 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | OTO-201 | 6 mg OTO-201 OTO-201 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Ears With Otorrhea (Drainage From the Middle Ear) | Acute otitis media with tympanostomy tubes in place (AOMT) refers to subjects that have ear tubes present, but have a middle ear infection. Otorrhea is fluid drainage from the middle ear. This outcome is assessed during the otoscopic examination of each affected ear (the ear with the infection). All subjects have otorrhea in the affected ear at Baseline and the assessment is done after administering OTO-201 to be sure there is no infection remaining or no new infection. | Safety analysis set: All enrolled and treated subjects; subjects could have either unilateral or bilateral (one ear or both ears) acute otitis media with tympanostomy tubes in place (AOMT) | Posted | Count of Units | affected ears | Day 29 | affected ears | affected ears |
|
1 month
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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 | OTO-201 | 6 mg OTO-201 OTO-201 | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA (16.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information Call Center | Otonomy, Inc. | 1-800-826-6411 | medinfo@otonomy.com |
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| ID | Term |
|---|---|
| D010033 | Otitis Media |
| ID | Term |
|---|---|
| D010031 | Otitis |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| Day 15 |
| Fort Lauderdale |
| Florida |
| United States |
| Charlotte Eye, Ear, Nose and Throat Associates | Charlotte | North Carolina | United States |
| Charlotte Eye, Ear, Nose and Throat Associates | Matthews | North Carolina | United States |
| Carolina Ear, Nose and Throat | Orangeburg | South Carolina | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Feasibility of Administration Questionnaire | Issues Administering OTO-201 onto the Tympanic Membrane and the Auditory Canal-facing Side of the Tympanostomy Tube (answered "yes") | Safety analysis set: All enrolled and treated subjects. | Posted | Count of Units | ears | Day 1 | ears | ears |
|
|
|
| Secondary | Number of Ears With no More Otorrhea (Drainage From the Middle Ear) | Acute otitis media with tympanostomy tubes in place (AOMT) refers to subjects that have ear tubes present, but have a middle ear infection. Otorrhea is fluid drainage from the middle ear. This outcome is assessed during the otoscopic examination of each affected ear (the ear with the infection). All subjects have otorrhea in the affected ear at Baseline and the assessment is done 15 days after administering OTO-201 to see if it worked and there is no more drainage from the middle ear. | Safety analysis set: All enrolled and treated subjects | Posted | Count of Units | affected ears | Day 15 | affected ears | affected ears |
|
|
|
| 39 |
| 0 |
| 39 |
| 23 |
| 39 |
| Device Extrusion | General disorders | MedDRA (16.1) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
|
| Otitis Media | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
|
| Otitis Media Acute | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
|
| Pharyngitis Streptococcal | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
|
| Seasonal Allergy | Immune system disorders | MedDRA (16.1) | Systematic Assessment |
|
Publication subject to Sponsor consent.