Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes
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
1 other identifier
interventional
501
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2015
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 5, 2015
CompletedFirst Posted
Study publicly available on registry
November 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedResults Posted
Study results publicly available
September 22, 2020
CompletedOctober 19, 2020
September 1, 2020
9 months
November 5, 2015
September 1, 2020
September 21, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Subjects With Post-surgical Otorrhea
Absence or presence of otorrhea (drainage from the middle ear)
Week 4
Number of Subjects With Post-surgical Otorrhea
Absence or presence of otorrhea (drainage from the middle ear)
8 weeks
Secondary Outcomes (4)
Adverse Events
Up to Eight Weeks
Caregiver Burden - Ear Discharge Control
Week 4
Caregiver Burden - Ear Discharge Control
Week 8
Caregiver Burden - Ear Drops Administration
Week 8
Study Arms (1)
0.1 mL OTO-201
EXPERIMENTALCiprofloxacin
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Otonomy, Inc.lead
Study Sites (1)
Email Otonomy Central Contact for Trial Locations
San Diego, California, 92121, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Information Call Center
- Organization
- Otonomy, Inc.
Study Officials
- STUDY CHAIR
Dean Hakanson, MD
Otonomy, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2015
First Posted
November 9, 2015
Study Start
October 1, 2015
Primary Completion
July 1, 2016
Study Completion
July 1, 2016
Last Updated
October 19, 2020
Results First Posted
September 22, 2020
Record last verified: 2020-09