OTO-201 for Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement
A Prospective, Randomized, Double-Blind, Placebo- and Sham-Controlled, Multicenter, Phase 1b Study of OTO-201 Given as a Single Intratympanic Injection for Intra-Operative Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement
1 other identifier
interventional
83
1 country
1
Brief Summary
The purpose of this study is to describe the safety and tolerability of two dose levels of OTO-201, placebo and sham when administered intra-operatively in pediatric subjects with bilateral middle ear effusion who require tympanostomy tube placement.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2012
Shorter than P25 for phase_1
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
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 18, 2012
CompletedFirst Posted
Study publicly available on registry
December 24, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedJune 19, 2013
June 1, 2013
6 months
December 18, 2012
June 17, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Safety
Evaluation of adverse events, otoscopic exams, audiometry, and tympanometry
Up to 1 month
Secondary Outcomes (2)
Clinical Activity
Up to 1 month
Microbiological Eradication
Up to 1 month
Study Arms (4)
4 mg OTO-201
EXPERIMENTAL12 mg OTO-201
EXPERIMENTALVehicle for OTO-201
PLACEBO COMPARATORSham
SHAM COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Subject is a male or female aged 6 months to 12 years, inclusive
- Subject has a clinical diagnosis of bilateral middle ear effusion requiring 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 tympanostomy tube placement
- Subject has a history of sensorineural hearing loss
- Subject has a history of chronic or recurrent bacterial infections other than otitis media that likely will require treatment with antibiotics during the course of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Otonomy, Inc.lead
Study Sites (1)
Call/Email Otonomy Central Contact for Trial Locations
San Diego, California, 92121, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Carl LeBel, PhD
Otonomy, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2012
First Posted
December 24, 2012
Study Start
December 1, 2012
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
June 19, 2013
Record last verified: 2013-06