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Dose Ranging Study of OTO-201 in AOMT
This is a 1-month, prospective, multicenter, randomized, dose-ranging, sham-controlled, blinded study in which eligible subjects with either unilateral or bilateral acute otitis media with tympanostomy tubes (AOMT) will receive a single administration of 6 mg OTO-201, 12 mg OTO-201, or sham into the affected ear(s).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 6 mg OTO-201 | Experimental | 6 mg OTO-201 (sustained-release suspension of ciprofloxacin), single 0.1 mL supra-tympanostomy tube (STT) administration to the affected ear(s) |
|
| 12 mg OTO-201 | Experimental | 12 mg OTO-201 (sustained-release suspension of ciprofloxacin), single 0.2 mL supra-tympanostomy tube (STT) administration to the affected ear(s) |
|
| Sham (empty syringe) | Sham Comparator | Sham (empty syringe), single 0.1 mL STT administration to the affected ear(s) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 6 mg ciprofloxacin | Drug | Single administration of OTO-201 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Adverse Events | Number of subjects with adverse events during the study from dosing up to 1 month after dosing | Up to 1 month |
| Otoscopic Examination: Auricle and Meatus | Number of affected ears (i.e., those ears that were infected) whose external ear and ear canal (auricle and meatus), when examined through an otoscope, appeared normal at Baseline and appeared abnormal at Day 29. The auricle and meatus of each infected ear was examined using an otoscope and was assessed as either normal or abnormal at every visit. This outcome looks to see if there was a worsening of the condition of the auricle and meatus with treatment (i.e., a safety measure). | Up to 1 month |
| Otoscopic Examination: Tympanic Membrane | Number of affected ears (i.e., those ears that were infected) whose ear drum (tympanic membrane), when examined through an otoscope, appeared normal at Baseline and appeared abnormal at Day 29. The tympanic membrane of each infected ear was examined using an otoscope and was assessed as either normal or abnormal at every visit. This outcome looks to see if there was a worsening of the condition of the tympanic membrane with treatment (i.e., a safety measure). | Up to 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Absence of Otorrhea | Absence of otorrhea (middle ear drainage) | Up to Two Weeks |
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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 |
|---|---|---|---|---|---|---|
| Contact Otonomy call center for trial locations | San Diego | California | 92121 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 6 mg OTO-201 | 6 mg ciprofloxacin: single administration of OTO-201 |
| FG001 | 12 mg OTO-201 | 12 mg ciprofloxacin: single administration of OTO-201 |
| FG002 | Control | Sham Control: simulated, single administration |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
95 subjects randomized (19 sham, 38 6mg, 3812mg OTO-201). 1 sham and 1 6mg subject positive for Group A strep and not in intento to treat (ITT) population (Baseline and efficacy) leaving 18 sham, 37-6mg OTO-201, 38-12 mg OTO-201 in ITT. Safety population (AE/SAE) = randomized (19 sham, 38 6mg, 38 12mg).
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| ID | Title | Description |
|---|---|---|
| BG000 | 6 mg OTO-201 | 6 mg ciprofloxacin: single administration of OTO-201 |
| BG001 | 12 mg OTO-201 | 12 mg ciprofloxacin: single administration of 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 Subjects With Adverse Events | Number of subjects with adverse events during the study from dosing up to 1 month after dosing | Safety analysis set: all subjects who received study drug. | Posted | Count of Participants | Participants | Up to 1 month |
|
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 administration of OTO-201 | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Otitis media acute | 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 |
| ID | Term |
|---|---|
| D010031 | Otitis |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D002939 | Ciprofloxacin |
| C005703 | salicylhydroxamic acid |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| 12 mg ciprofloxacin | Drug | Single administration of OTO-201 |
|
|
| Sham | Other |
|
| BG002 | Control | Sham Control: simulated, single administration |
| BG003 | Total | Total of all reporting groups |
| 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 |
|
Sham Control: simulated, single administration |
|
|
| Primary | Otoscopic Examination: Auricle and Meatus | Number of affected ears (i.e., those ears that were infected) whose external ear and ear canal (auricle and meatus), when examined through an otoscope, appeared normal at Baseline and appeared abnormal at Day 29. The auricle and meatus of each infected ear was examined using an otoscope and was assessed as either normal or abnormal at every visit. This outcome looks to see if there was a worsening of the condition of the auricle and meatus with treatment (i.e., a safety measure). | Safety Population (19 sham, 38 6mg, 38 12 mg) who could have had one or 2 affected ears at Baseline (that is, it was not necessary for both ears to be infected to take part in the study). This is why the number of ears in each group do not equal twice the number of participants. | Posted | Number | abnormal affected ears at Day 29 | Up to 1 month | normal affected ears at Baseline | normal affected ears at Baseline |
|
|
|
| Primary | Otoscopic Examination: Tympanic Membrane | Number of affected ears (i.e., those ears that were infected) whose ear drum (tympanic membrane), when examined through an otoscope, appeared normal at Baseline and appeared abnormal at Day 29. The tympanic membrane of each infected ear was examined using an otoscope and was assessed as either normal or abnormal at every visit. This outcome looks to see if there was a worsening of the condition of the tympanic membrane with treatment (i.e., a safety measure). | Safety Population (19 sham, 38 6mg, 38 12 mg) who could have had one or 2 affected ears at Baseline (that is, it was not necessary for both ears to be infected to take part in the study). This is why the number of ears in each group do not equal twice the number of participants. | Posted | Number | abnormal ears at Day 29 | Up to 1 month | normal affected ears at Baseline | normal affected ears at Baseline |
|
|
|
| Secondary | Absence of Otorrhea | Absence of otorrhea (middle ear drainage) | Modified intent-to-treat analysis set: all subjects who were randomized, received treatment, did not have group A streptococci cultured on Visit 1 (Day 1), and had at least 1 on-therapy visit. | Posted | Count of Participants | Participants | Up to Two Weeks |
|
|
|
| 38 |
| 0 |
| 38 |
| 5 |
| 38 |
| EG001 | 12 mg OTO-201 | 12 mg ciprofloxacin: single administration of OTO-201 | 0 | 38 | 0 | 38 | 6 | 38 |
| EG002 | Control | Sham Control: simulated, single administration | 0 | 19 | 0 | 19 | 1 | 19 |
| Pyrexia | General disorders | MedDRA (18.1) | Systematic Assessment |
|
Publication subject to Sponsor consent.
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |