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Open-Label Study of OTO-201 for Treatment of AOMT

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ClinicalTrials.gov Identifier: NCT02408796
Recruitment Status : Completed
First Posted : April 3, 2015
Results First Posted : September 23, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Otonomy, Inc.

Brief Summary:
This is a 1-month, prospective, multicenter, open-label study in pediatric subjects with either unilateral or bilateral acute otitis media with tympanostomy tubes (AOMT). Eligible subjects will receive a single dose of 6 mg OTO-201 to the affected ear(s). The study is designed to characterize safety, procedural factors and clinical effect of OTO-201 administered in subjects with AOMT.

Condition or disease Intervention/treatment Phase
Acute Otitis Media AOMT Drug: OTO-201 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 1-Month, Prospective, Multicenter, Open-Label Study of OTO-201 Given as a Single Supra-Tympanostomy Tube Administration for Treatment of Acute Otitis Media With Tympanostomy Tubes in Pediatric Subjects
Study Start Date : March 2015
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections

Arm Intervention/treatment
Experimental: OTO-201
6 mg OTO-201
Drug: OTO-201



Primary Outcome Measures :
  1. Number of Ears With Otorrhea (Drainage From the Middle Ear) [ Time Frame: Day 29 ]
    Acute otitis media with tympanostomy tubes in place (AOMT) refers to subjects that have ear tubes present, but have a middle ear infection. Otorrhea is fluid drainage from the middle ear. This outcome is assessed during the otoscopic examination of each affected ear (the ear with the infection). All subjects have otorrhea in the affected ear at Baseline and the assessment is done after administering OTO-201 to be sure there is no infection remaining or no new infection.

  2. Feasibility of Administration Questionnaire [ Time Frame: Day 1 ]
    Issues Administering OTO-201 onto the Tympanic Membrane and the Auditory Canal-facing Side of the Tympanostomy Tube (answered "yes")


Secondary Outcome Measures :
  1. Number of Ears With no More Otorrhea (Drainage From the Middle Ear) [ Time Frame: Day 15 ]
    Acute otitis media with tympanostomy tubes in place (AOMT) refers to subjects that have ear tubes present, but have a middle ear infection. Otorrhea is fluid drainage from the middle ear. This outcome is assessed during the otoscopic examination of each affected ear (the ear with the infection). All subjects have otorrhea in the affected ear at Baseline and the assessment is done 15 days after administering OTO-201 to see if it worked and there is no more drainage from the middle ear.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria includes, but is not limited to:

  • Subject is a male or female aged 6 months to 17 years, inclusive
  • 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 includes, but is not limited to:

  • Subject has a history of sensorineural hearing loss
  • Subject has tympanic membrane perforation other than the surgical tympanostomy tube perforation
  • Subject has a history of known immunodeficiency disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02408796


Locations
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United States, California
Central California Ear, Nose and Throat
Fresno, California, United States
United States, Florida
South Florida Pediatric Otolaryngology
Fort Lauderdale, Florida, United States
United States, North Carolina
Charlotte Eye, Ear, Nose and Throat Associates
Charlotte, North Carolina, United States
Charlotte Eye, Ear, Nose and Throat Associates
Matthews, North Carolina, United States
United States, South Carolina
Carolina Ear, Nose and Throat
Orangeburg, South Carolina, United States
Sponsors and Collaborators
Otonomy, Inc.
Investigators
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Study Chair: Carl LeBel, PhD Otonomy, Inc.
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Responsible Party: Otonomy, Inc.
ClinicalTrials.gov Identifier: NCT02408796    
Other Study ID Numbers: 201-201505
First Posted: April 3, 2015    Key Record Dates
Results First Posted: September 23, 2020
Last Update Posted: October 19, 2020
Last Verified: September 2020
Keywords provided by Otonomy, Inc.:
Acute otitis media with tympanostomy tubes
Additional relevant MeSH terms:
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Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases