Back to resultsOpen-Label Study of OTO-201 for Treatment of AOMT
Primary Purpose
Acute Otitis Media, AOMT
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
OTO-201
Sponsored by
About this trial
This is an interventional treatment trial for Acute Otitis Media focused on measuring Acute otitis media with tympanostomy tubes
Eligibility 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
Sites / Locations
- Central California Ear, Nose and Throat
- South Florida Pediatric Otolaryngology
- Charlotte Eye, Ear, Nose and Throat Associates
- Charlotte Eye, Ear, Nose and Throat Associates
- Carolina Ear, Nose and Throat
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
OTO-201
Arm Description
6 mg OTO-201
Outcomes
Primary Outcome Measures
Number of Ears With Otorrhea (Drainage From the Middle Ear)
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
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)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02408796
Brief Title
Open-Label Study of OTO-201 for Treatment of AOMT
Official Title
A 1-Month, Prospective, Multicenter, Open-Label Study of OTO-201 Given as a Single Supra-Tympanostomy Tube Administration for Treatment of Acute Otitis Media With Tympanostomy Tubes in Pediatric Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otonomy, Inc.
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Otitis Media, AOMT
Keywords
Acute otitis media with tympanostomy tubes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OTO-201
Arm Type
Experimental
Arm Description
6 mg OTO-201
Intervention Type
Drug
Intervention Name(s)
OTO-201
Primary Outcome Measure Information:
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
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
Secondary Outcome Measure Information:
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carl LeBel, PhD
Organizational Affiliation
Otonomy, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Central California Ear, Nose and Throat
City
Fresno
State/Province
California
Country
United States
Facility Name
South Florida Pediatric Otolaryngology
City
Fort Lauderdale
State/Province
Florida
Country
United States
Facility Name
Charlotte Eye, Ear, Nose and Throat Associates
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
Charlotte Eye, Ear, Nose and Throat Associates
City
Matthews
State/Province
North Carolina
Country
United States
Facility Name
Carolina Ear, Nose and Throat
City
Orangeburg
State/Province
South Carolina
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Open-Label Study of OTO-201 for Treatment of AOMT
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