Back to resultsOpen-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes
Primary Purpose
Otitis Media
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
OTO-201 (ciprofloxacin)
Sponsored by
About this trial
This is an interventional treatment trial for Otitis Media focused on measuring Otitis media, Ear infection, 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 history of otitis media requiring bilateral tympanostomy tube placement
- Subject's caregiver is willing to comply with the protocol and attend all study visits
Exclusion Criteria includes, but is not limited to:
- Subject has a history of prior ear or mastoid surgery, not including myringotomy or myringotomy with TT placement
- Subject has been designated for any other surgical procedure that would occur concurrently with TT placement, except adenoidectomy, airway endoscopy, nasal endoscopy, and nasal cautery for epistaxis
- Subject has a history of sensorineural hearing loss
Sites / Locations
- Email Otonomy Central Contact for Trial Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
0.1 mL OTO-201
Arm Description
Ciprofloxacin
Outcomes
Primary Outcome Measures
Number of Subjects With Post-surgical Otorrhea
Absence or presence of otorrhea (drainage from the middle ear)
Number of Subjects With Post-surgical Otorrhea
Absence or presence of otorrhea (drainage from the middle ear)
Secondary Outcome Measures
Adverse Events
Evaluation of adverse events
Caregiver Burden - Ear Discharge Control
Ear Drop Caregiver Burden Questionnaire at Week 4
Caregiver Burden - Ear Discharge Control
Ear Drop Caregiver Burden Questionnaire at Week 8
Caregiver Burden - Ear Drops Administration
Ear Drop Caregiver Burden Questionnaire at Week 8
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02600559
Brief Title
Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes
Official Title
An 8-Week, Prospective, Multicenter, Open-Label Study of OTO-201 Given as a Single Administration in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
July 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
This is an 8-week, multicenter, open-label study in which eligible subjects with a history of otitis media requiring TT placement will receive 6 mg OTO-201 to each ear. The study is designed to evaluate the safety and efficacy of OTO-201 in subjects undergoing TT placement with common concurrent surgeries and any middle ear effusion status.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otitis Media
Keywords
Otitis media, Ear infection, Tympanostomy tubes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
501 (Actual)
8. Arms, Groups, and Interventions
Arm Title
0.1 mL OTO-201
Arm Type
Experimental
Arm Description
Ciprofloxacin
Intervention Type
Drug
Intervention Name(s)
OTO-201 (ciprofloxacin)
Other Intervention Name(s)
OTIPRIO
Primary Outcome Measure Information:
Title
Number of Subjects With Post-surgical Otorrhea
Description
Absence or presence of otorrhea (drainage from the middle ear)
Time Frame
Week 4
Title
Number of Subjects With Post-surgical Otorrhea
Description
Absence or presence of otorrhea (drainage from the middle ear)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Adverse Events
Description
Evaluation of adverse events
Time Frame
Up to Eight Weeks
Title
Caregiver Burden - Ear Discharge Control
Description
Ear Drop Caregiver Burden Questionnaire at Week 4
Time Frame
Week 4
Title
Caregiver Burden - Ear Discharge Control
Description
Ear Drop Caregiver Burden Questionnaire at Week 8
Time Frame
Week 8
Title
Caregiver Burden - Ear Drops Administration
Description
Ear Drop Caregiver Burden Questionnaire at Week 8
Time Frame
Week 8
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 history of otitis media requiring bilateral tympanostomy tube placement
Subject's caregiver is willing to comply with the protocol and attend all study visits
Exclusion Criteria includes, but is not limited to:
Subject has a history of prior ear or mastoid surgery, not including myringotomy or myringotomy with TT placement
Subject has been designated for any other surgical procedure that would occur concurrently with TT placement, except adenoidectomy, airway endoscopy, nasal endoscopy, and nasal cautery for epistaxis
Subject has a history of sensorineural hearing loss
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dean Hakanson, MD
Organizational Affiliation
Otonomy, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Email Otonomy Central Contact 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
Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes
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