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This is a 1-month, prospective, multicenter, open-label study in pediatric subjects with bilateral middle ear effusion requiring tympanostomy tube placement. Eligible subjects will receive a single dose to each ear of 6 mg OTO-201, administered intraoperatively into the middle ear through the lumen of the tympanostomy tube (trans-tympanostomy tube TTT). The study is designed to characterize safety and any procedural issues associated with TTT drug administration of OTO-201.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OTO-201 | Experimental | 6 mg OTO-201 administered trans-tympanostomy tube |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OTO-201 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Otoscopic Examination: Auricle and Meatus | Number of ears whose external ear and ear canal (auricle and meatus), when examined through an otoscope, appeared normal at Baseline and appeared abnormal at Day 29 | Up to 1 month |
| Otoscopic Examination: Tympanic Membrane | Number of ears whose ear drum (tympanic membrane), when examined through an otoscope, appeared normal at Baseline and appeared abnormal at Day 29 | up to 1 month |
| Otoscopic Examination: Tube Patency | Subjects with at least one ear tube patent (i.e., not blocked) at Day 29 | Up to 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Administration | Ease of administering OTO-201 through the tympanostomy tube: Number of subjects that investigators rated ease of administration as either "easy" or "very easy" | Day 1 |
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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 | |||
| Charlotte Eye, Ear, Nose and Throat Associates |
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| ID | Title | Description |
|---|---|---|
| FG000 | 6 mg OTO-201 | 6 mg ciprofloxacin: single Trans-Tympanic Tube Administration |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 6 mg OTO-201 | 6 mg ciprofloxacin: single Trans-Tympanic Tube Administration |
| 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 | Otoscopic Examination: Auricle and Meatus | Number of ears whose external ear and ear canal (auricle and meatus), when examined through an otoscope, appeared normal at Baseline and appeared abnormal at Day 29 | Safety analysis set : consisted of all enrolled and treated subjects | Posted | Count of Units | ears | Up to 1 month | ears | ears |
|
|
Adverse events were reported during dosing and up to 1 month following dosing.
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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 | 6 mg OTO-201 | 6 mg ciprofloxacin: single Trans-Tympanic Tube Administration | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | 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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| Charlotte |
| North Carolina |
| United States |
| Charlotte Eye, Ear, Nose and Throat Associates | Matthews | North Carolina | United States |
| Piedmont Ear, Nose and Throat | Winston-Salem | North Carolina | United States |
| Carolina Ear, Nose and Throat | Orangeburg | South Carolina | United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ears |
|
|
| Primary | Otoscopic Examination: Tympanic Membrane | Number of ears whose ear drum (tympanic membrane), when examined through an otoscope, appeared normal at Baseline and appeared abnormal at Day 29 | Safety analysis set: all enrolled and treated subjects | Posted | Count of Units | ears | up to 1 month | ears | ears |
|
|
|
| Primary | Otoscopic Examination: Tube Patency | Subjects with at least one ear tube patent (i.e., not blocked) at Day 29 | Safety analysis set: all enrolled and treated subjects | Posted | Count of Participants | Participants | Up to 1 month |
|
|
|
| Secondary | Feasibility of Administration | Ease of administering OTO-201 through the tympanostomy tube: Number of subjects that investigators rated ease of administration as either "easy" or "very easy" | Safety analysis set consisted of all enrolled and treated subjects | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| 33 |
| 0 |
| 33 |
| 20 |
| 33 |
| Upper Respiratory Infection | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
|
| Ear Pain | Ear and labyrinth disorders | MedDRA (16.1) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (16.1) | Systematic Assessment |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
|
Publication subject to Sponsor consent.