OTO-201 for Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement
NCT ID: NCT01755286
Last Updated: 2013-06-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
83 participants
INTERVENTIONAL
2012-12-31
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
TRIPLE
Study Groups
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4 mg OTO-201
OTO-201
Single intra-operative injection
12 mg OTO-201
OTO-201
Single intra-operative injection
Vehicle for OTO-201
Placebo
Single intratympanic injection
Sham
Sham
Simulated single intratympanic injection
Interventions
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OTO-201
Single intra-operative injection
Placebo
Single intratympanic injection
Sham
Simulated single intratympanic injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
6 Months
12 Years
ALL
No
Sponsors
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Otonomy, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Carl LeBel, PhD
Role: STUDY_CHAIR
Otonomy, Inc.
Locations
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Call/Email Otonomy Central Contact for Trial Locations
San Diego, California, United States
Countries
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Other Identifiers
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201-201101
Identifier Type: -
Identifier Source: org_study_id
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