Acute Otitis Media, AOMT
Conditions
Keywords
Acute otitis media with tympanostomy tubes, OTIPRIO
Brief summary
Dose Ranging Study of OTO-201 in AOMT
Detailed description
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).
Interventions
DRUG6 mg ciprofloxacin
Single administration of OTO-201
Single administration of OTO-201
OTHERSham
Sponsors
Otonomy, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
6 Months to 17 Years
Healthy volunteers
No
Inclusion criteria
includes, but is not limited to: * Subject is a male or female aged 6 months to 17 years, inclusive * Subject has a clinical diagnosis of acute otitis media with tympanostomy tubes (AOMT) * Subject's caregiver is willing to comply with the protocol an attend all study visits
Exclusion criteria
includes, but is not limited to: * Subject has a history of sensorineural hearing loss * Subject has tympanic membrane perforation other than the surgical tympanostomy tube perforation * Subject has a history of known immunodeficiency disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Adverse Events | Up to 1 month | Number of subjects with adverse events during the study from dosing up to 1 month after dosing |
| Otoscopic Examination: Auricle and Meatus | Up to 1 month | 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). |
| Otoscopic Examination: Tympanic Membrane | Up to 1 month | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absence of Otorrhea | Up to Two Weeks | Absence of otorrhea (middle ear drainage) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 6 mg OTO-201 6 mg ciprofloxacin: single administration of OTO-201 | 37 |
| 12 mg OTO-201 12 mg ciprofloxacin: single administration of OTO-201 | 38 |
| Control Sham Control: simulated, single administration | 18 |
| Total | 93 |
Baseline characteristics
| Characteristic | 6 mg OTO-201 | Total | Control | 12 mg OTO-201 |
|---|---|---|---|---|
| Age, Continuous | 3.004 years STANDARD_DEVIATION 3.0546 | 3.498 years STANDARD_DEVIATION 2.8915 | 3.551 years STANDARD_DEVIATION 2.4583 | 3.955 years STANDARD_DEVIATION 2.9111 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 8 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants | 84 Participants | 16 Participants | 35 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 22 Participants | 5 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 3 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 29 Participants | 67 Participants | 11 Participants | 27 Participants |
| Region of Enrollment United States | 37 participants | 93 participants | 18 participants | 38 participants |
| Sex: Female, Male Female | 15 Participants | 40 Participants | 7 Participants | 18 Participants |
| Sex: Female, Male Male | 22 Participants | 53 Participants | 11 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 38 | 0 / 19 |
| other Total, other adverse events | 5 / 38 | 6 / 38 | 1 / 19 |
| serious Total, serious adverse events | 0 / 38 | 0 / 38 | 0 / 19 |
Outcome results
Primary
Number of Subjects With Adverse Events
Number of subjects with adverse events during the study from dosing up to 1 month after dosing
Time frame: Up to 1 month
Population: Safety analysis set: all subjects who received study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 6 mg OTO-201 | Number of Subjects With Adverse Events | 19 Participants |
| 12 mg OTO-201 | Number of Subjects With Adverse Events | 14 Participants |
| Control | Number of Subjects With Adverse Events | 4 Participants |
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).
Time frame: Up to 1 month
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 6 mg OTO-201 | Otoscopic Examination: Auricle and Meatus | 2 abnormal affected ears at Day 29 |
| 12 mg OTO-201 | Otoscopic Examination: Auricle and Meatus | 0 abnormal affected ears at Day 29 |
| Control | Otoscopic Examination: Auricle and Meatus | 0 abnormal affected ears at Day 29 |
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).
Time frame: Up to 1 month
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 6 mg OTO-201 | Otoscopic Examination: Tympanic Membrane | 1 abnormal ears at Day 29 |
| 12 mg OTO-201 | Otoscopic Examination: Tympanic Membrane | 0 abnormal ears at Day 29 |
| Control | Otoscopic Examination: Tympanic Membrane | 0 abnormal ears at Day 29 |
Secondary
Absence of Otorrhea
Absence of otorrhea (middle ear drainage)
Time frame: Up to Two Weeks
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 6 mg OTO-201 | Absence of Otorrhea | 20 Participants |
| 12 mg OTO-201 | Absence of Otorrhea | 23 Participants |
| Control | Absence of Otorrhea | 2 Participants |