OTO-201 for the Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement
NCT ID: NCT01949155
Last Updated: 2016-11-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
266 participants
INTERVENTIONAL
2013-11-30
2014-05-31
Brief Summary
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Detailed Description
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Study subjects are required to have a clinical diagnosis of bilateral middle ear effusion requiring TT placement. On the day of surgery, prior to surgery, eligible subjects were examined via otoscope to confirm bilateral middle ear effusion. Subjects with bilateral middle ear effusion were randomized to either 6 mg OTO-201 or sham. Subjects without bilateral effusion on the day of surgery were not randomized and were considered screen failures.
Approximately 264 subjects are planned to be randomized to OTO-201 or sham using a 2:1 allocation ratio. Randomization to OTO-201 or sham was stratified by age: 6 months to 2 years or \>2 years.
Subjects are to visit the study site for safety assessments and otoscopic examination on Days 4, 8, 15, and 29. The assessment of otorrhea by the blinded assessor for the primary efficacy endpoint occurred on Days 4, 8, and 15.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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OTO-201
OTO-201: Single, intratympanic injection:
One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery.
OTO-201
Single, intratympanic injection
Sham
Sham: Simulated single, intratympanic injection:
One sham injection into each ear during surgery.
Sham
Simulated single, intratympanic injection
Interventions
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OTO-201
Single, intratympanic injection
Sham
Simulated single, intratympanic injection
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
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_DIRECTOR
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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References
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Mair EA, Park AH, Don D, Koempel J, Bear M, LeBel C. Safety and Efficacy of Intratympanic Ciprofloxacin Otic Suspension in Children With Middle Ear Effusion Undergoing Tympanostomy Tube Placement: Two Randomized Clinical Trials. JAMA Otolaryngol Head Neck Surg. 2016 May 1;142(5):444-51. doi: 10.1001/jamaoto.2016.0001.
Other Identifiers
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201-201303
Identifier Type: -
Identifier Source: org_study_id