Back to resultsDose Ranging Study of OTO-201 in AOMT
Primary Purpose
Acute Otitis Media, AOMT
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
6 mg ciprofloxacin
12 mg ciprofloxacin
Sham
Sponsored by
About this trial
This is an interventional treatment trial for Acute Otitis Media focused on measuring Acute otitis media with tympanostomy tubes, OTIPRIO
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
- Contact Otonomy call center for trial locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Sham Comparator
Arm Label
6 mg OTO-201
12 mg OTO-201
Sham (empty syringe)
Arm Description
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 (sustained-release suspension of ciprofloxacin), single 0.2 mL supra-tympanostomy tube (STT) administration to the affected ear(s)
Sham (empty syringe), single 0.1 mL STT administration to the affected ear(s)
Outcomes
Primary Outcome Measures
Number of Subjects With Adverse Events
Number of subjects with adverse events during the study from dosing up to 1 month after dosing
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).
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).
Secondary Outcome Measures
Absence of Otorrhea
Absence of otorrhea (middle ear drainage)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02719158
Brief Title
Dose Ranging Study of OTO-201 in AOMT
Official Title
A 1-Month, Prospective, Multicenter, Randomized, Dose-Ranging, Sham-Controlled, Blinded Study of OTO-201 Given as a Single 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
February 2016 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
July 2016 (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
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).
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, OTIPRIO
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
95 (Actual)
8. Arms, Groups, and Interventions
Arm Title
6 mg OTO-201
Arm Type
Experimental
Arm Description
6 mg OTO-201 (sustained-release suspension of ciprofloxacin), single 0.1 mL supra-tympanostomy tube (STT) administration to the affected ear(s)
Arm Title
12 mg OTO-201
Arm Type
Experimental
Arm Description
12 mg OTO-201 (sustained-release suspension of ciprofloxacin), single 0.2 mL supra-tympanostomy tube (STT) administration to the affected ear(s)
Arm Title
Sham (empty syringe)
Arm Type
Sham Comparator
Arm Description
Sham (empty syringe), single 0.1 mL STT administration to the affected ear(s)
Intervention Type
Drug
Intervention Name(s)
6 mg ciprofloxacin
Other Intervention Name(s)
OTIPRIO
Intervention Description
Single administration of OTO-201
Intervention Type
Drug
Intervention Name(s)
12 mg ciprofloxacin
Other Intervention Name(s)
OTIPRIO
Intervention Description
Single administration of OTO-201
Intervention Type
Other
Intervention Name(s)
Sham
Primary Outcome Measure Information:
Title
Number of Subjects With Adverse Events
Description
Number of subjects with adverse events during the study from dosing up to 1 month after dosing
Time Frame
Up to 1 month
Title
Otoscopic Examination: Auricle and Meatus
Description
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
Title
Otoscopic Examination: Tympanic Membrane
Description
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
Secondary Outcome Measure Information:
Title
Absence of Otorrhea
Description
Absence of otorrhea (middle ear drainage)
Time Frame
Up to Two Weeks
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
Contact Otonomy call center for trial locations
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Dose Ranging Study of OTO-201 in AOMT
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