Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
95 participants
INTERVENTIONAL
2016-02-29
2016-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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6 mg OTO-201
6 mg OTO-201 (sustained-release suspension of ciprofloxacin), single 0.1 mL supra-tympanostomy tube (STT) administration to the affected ear(s)
6 mg ciprofloxacin
Single administration of OTO-201
12 mg OTO-201
12 mg OTO-201 (sustained-release suspension of ciprofloxacin), single 0.2 mL supra-tympanostomy tube (STT) administration to the affected ear(s)
12 mg ciprofloxacin
Single administration of OTO-201
Sham (empty syringe)
Sham (empty syringe), single 0.1 mL STT administration to the affected ear(s)
Sham
Interventions
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6 mg ciprofloxacin
Single administration of OTO-201
12 mg ciprofloxacin
Single administration of OTO-201
Sham
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Subject has tympanic membrane perforation other than the surgical tympanostomy tube perforation
* Subject has a history of known immunodeficiency disease
6 Months
17 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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San Diego, California, United States
Countries
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Other Identifiers
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201-201508
Identifier Type: -
Identifier Source: org_study_id
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