Open-Label Study of OTO-201 for Treatment of AOMT
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: OTO-201 6 mg OTO-201 |
Drug: OTO-201
|
Outcome Measures
Primary Outcome Measures
- Number of Ears With Otorrhea (Drainage From the Middle Ear) [Day 29]
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.
- Feasibility of Administration Questionnaire [Day 1]
Issues Administering OTO-201 onto the Tympanic Membrane and the Auditory Canal-facing Side of the Tympanostomy Tube (answered "yes")
Secondary Outcome Measures
- Number of Ears With no More Otorrhea (Drainage From the Middle Ear) [Day 15]
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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Central California Ear, Nose and Throat | Fresno | California | United States | |
| 2 | South Florida Pediatric Otolaryngology | Fort Lauderdale | Florida | United States | |
| 3 | Charlotte Eye, Ear, Nose and Throat Associates | Charlotte | North Carolina | United States | |
| 4 | Charlotte Eye, Ear, Nose and Throat Associates | Matthews | North Carolina | United States | |
| 5 | Carolina Ear, Nose and Throat | Orangeburg | South Carolina | United States |
Sponsors and Collaborators
- Otonomy, Inc.
Investigators
- Study Chair: Carl LeBel, PhD, Otonomy, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 201-201505
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | OTO-201 |
|---|---|
| Arm/Group Description | 6 mg OTO-201 OTO-201 |
| Period Title: Overall Study | |
| STARTED | 39 |
| COMPLETED | 39 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | OTO-201 |
|---|---|
| Arm/Group Description | 6 mg OTO-201 OTO-201 |
| Overall Participants | 39 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
2.16
(1.170)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
17
43.6%
|
| Male |
22
56.4%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
16
41%
|
| White |
22
56.4%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
1
2.6%
|
| Region of Enrollment (participants) [Number] | |
| United States |
39
100%
|
Outcome Measures
| Title | Number of Ears With Otorrhea (Drainage From the Middle Ear) |
|---|---|
| Description | 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. |
| Time Frame | Day 29 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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) |
| Arm/Group Title | OTO-201 |
|---|---|
| Arm/Group Description | 6 mg OTO-201 OTO-201 |
| Measure Participants | 39 |
| Measure affected ears | 58 |
| Count of Units [affected ears] |
8
|
| Title | Feasibility of Administration Questionnaire |
|---|---|
| Description | Issues Administering OTO-201 onto the Tympanic Membrane and the Auditory Canal-facing Side of the Tympanostomy Tube (answered "yes") |
| Time Frame | Day 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set: All enrolled and treated subjects. |
| Arm/Group Title | OTO-201 |
|---|---|
| Arm/Group Description | 6 mg OTO-201 OTO-201 |
| Measure Participants | 39 |
| Measure ears | 58 |
| Count of Units [ears] |
2
|
| Title | Number of Ears With no More Otorrhea (Drainage From the Middle Ear) |
|---|---|
| Description | 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. |
| Time Frame | Day 15 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set: All enrolled and treated subjects |
| Arm/Group Title | OTO-201 |
|---|---|
| Arm/Group Description | 6 mg OTO-201 OTO-201 |
| Measure Participants | 39 |
| Measure affected ears | 58 |
| Count of Units [affected ears] |
50
|
Adverse Events
| Time Frame | 1 month | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | OTO-201 | |
| Arm/Group Description | 6 mg OTO-201 OTO-201 | |
All Cause Mortality |
||
| OTO-201 | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/39 (0%) | |
Serious Adverse Events |
||
| OTO-201 | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/39 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| OTO-201 | ||
| Affected / at Risk (%) | # Events | |
| Total | 23/39 (59%) | |
| Gastrointestinal disorders | ||
| Diarrhea | 2/39 (5.1%) | |
| General disorders | ||
| Pyrexia | 9/39 (23.1%) | |
| Device Extrusion | 4/39 (10.3%) | |
| Immune system disorders | ||
| Seasonal Allergy | 2/39 (5.1%) | |
| Infections and infestations | ||
| Sinusitis | 3/39 (7.7%) | |
| Otitis Media | 2/39 (5.1%) | |
| Otitis Media Acute | 2/39 (5.1%) | |
| Pharyngitis Streptococcal | 2/39 (5.1%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Publication subject to Sponsor consent.
Results Point of Contact
| Name/Title | Medical Information Call Center |
|---|---|
| Organization | Otonomy, Inc. |
| Phone | 1-800-826-6411 |
| medinfo@otonomy.com |
- 201-201505