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This is an 8-week, multicenter, open-label study in which eligible subjects with a history of otitis media requiring TT placement will receive 6 mg OTO-201 to each ear. The study is designed to evaluate the safety and efficacy of OTO-201 in subjects undergoing TT placement with common concurrent surgeries and any middle ear effusion status.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.1 mL OTO-201 | Experimental | Ciprofloxacin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OTO-201 (ciprofloxacin) | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Post-surgical Otorrhea | Absence or presence of otorrhea (drainage from the middle ear) | Week 4 |
| Number of Subjects With Post-surgical Otorrhea | Absence or presence of otorrhea (drainage from the middle ear) | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Evaluation of adverse events | Up to Eight Weeks |
| Caregiver Burden - Ear Discharge Control | Ear Drop Caregiver Burden Questionnaire at Week 4 |
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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 |
|---|---|---|
| Dean Hakanson, MD | Otonomy, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Email Otonomy Central Contact for Trial Locations | San Diego | California | 92121 | United States |
There were a total of 518 subjects screened for this study. There were 17 subjects considered screen failures, with the majority (11) failing to meet inclusion/exclusion criteria. Therefore, 501 subjects were assigned for treatment in this study and are designated as "enrolled".
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| ID | Title | Description |
|---|---|---|
| FG000 | 6 mg OTO-201 | 6 mg ciprofloxacin: single administration |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 6 mg OTO-201 | 6 mg ciprofloxacin: single 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 | Number of Subjects With Post-surgical Otorrhea | Absence or presence of otorrhea (drainage from the middle ear) | Safety analysis set: All subjects who received study drug. | Posted | Count of Participants | Participants | Week 4 |
|
|
Adverse events were reported during dosing and up to 2 months following tympanostomy tube surgery.
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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 administration | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza | Infections and infestations | MedDRA (18.1) | Systematic Assessment | One of 4 adverse events that caused the subject to be hospitalized (also pneumonia, rhinovirus infection, and streptococcal infection); not related to study drug. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Respiratory Infection | Infections and infestations | MedDRA (18.1) | 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 |
| D010031 | Otitis |
| ID | Term |
|---|---|
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D002939 | Ciprofloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Week 4 |
| Caregiver Burden - Ear Discharge Control | Ear Drop Caregiver Burden Questionnaire at Week 8 | Week 8 |
| Caregiver Burden - Ear Drops Administration | Ear Drop Caregiver Burden Questionnaire at Week 8 | Week 8 |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| 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 |
|
| Medicaid (Yes/No) | Count of Participants | Participants |
|
|
| Primary | Number of Subjects With Post-surgical Otorrhea | Absence or presence of otorrhea (drainage from the middle ear) | Safety analysis set: All subjects who received study drug | Posted | Count of Participants | Participants | 8 weeks |
|
|
|
| Secondary | Adverse Events | Evaluation of adverse events | Safety analysis set: All subjects who received study drug. | Posted | Count of Participants | Participants | Up to Eight Weeks |
|
|
|
| Secondary | Caregiver Burden - Ear Discharge Control | Ear Drop Caregiver Burden Questionnaire at Week 4 | Safety analysis set: All subjects who received study drug and whose caregiver completed the questionnaire at Week 4 | Posted | Count of Participants | Participants | Week 4 |
|
|
|
| Secondary | Caregiver Burden - Ear Discharge Control | Ear Drop Caregiver Burden Questionnaire at Week 8 | Safety analysis set: All subjects who received study drug, and had a completed questionnaire at Week 8 | Posted | Count of Participants | Participants | Week 8 |
|
|
|
| Secondary | Caregiver Burden - Ear Drops Administration | Ear Drop Caregiver Burden Questionnaire at Week 8 | Safety analysis set: All subject who received study drug, and who had to be treated with ear drops after tube placement surgery. | Posted | Count of Participants | Participants | Week 8 |
|
|
|
| 501 |
| 1 |
| 501 |
| 200 |
| 501 |
|
| Nasopharyngitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Otitis Media | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Device occlusion | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Device extrusion | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Ear Pain | Ear and labyrinth disorders | MedDRA (18.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
|
Publication subject to Sponsor consent.
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |