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Open-Label Study of OTO-201 for Middle Ear Effusion Evaluating Trans-Tympanostomy Tube Administration

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ClinicalTrials.gov Identifier: NCT02350998
Recruitment Status : Completed
First Posted : January 30, 2015
Results First Posted : September 23, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Otonomy, Inc.

Study Description
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Brief Summary:
This is a 1-month, prospective, multicenter, open-label study in pediatric subjects with bilateral middle ear effusion requiring tympanostomy tube placement. Eligible subjects will receive a single dose to each ear of 6 mg OTO-201, administered intraoperatively into the middle ear through the lumen of the tympanostomy tube (trans-tympanostomy tube TTT). The study is designed to characterize safety and any procedural issues associated with TTT drug administration of OTO-201.

Condition or disease Intervention/treatment Phase
Bilateral Middle Ear Effusion Drug: OTO-201 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 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 Trans-Tympanic Tube Administration for Intra-Operative Treatment of Middle Ear Effusion in Pediatric Subjects With Otitis Media Requiring Tympanostomy Tube Placement
Study Start Date : January 2015
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015
Arms and Interventions
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Arm Intervention/treatment
Experimental: OTO-201
6 mg OTO-201 administered trans-tympanostomy tube
 Drug: OTO-201


Outcome Measures
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Primary Outcome Measures :
  1. Otoscopic Examination: Auricle and Meatus [ Time Frame: Up to 1 month ]
    Number of ears whose external ear and ear canal (auricle and meatus), when examined through an otoscope, appeared normal at Baseline and appeared abnormal at Day 29

  2. Otoscopic Examination: Tympanic Membrane [ Time Frame: up to 1 month ]
    Number of ears whose ear drum (tympanic membrane), when examined through an otoscope, appeared normal at Baseline and appeared abnormal at Day 29

  3. Otoscopic Examination: Tube Patency [ Time Frame: Up to 1 month ]
    Subjects with at least one ear tube patent (i.e., not blocked) at Day 29


Secondary Outcome Measures :
  1. Feasibility of Administration [ Time Frame: Day 1 ]
    Ease of administering OTO-201 through the tympanostomy tube: Number of subjects that investigators rated ease of administration as either "easy" or "very easy"


Eligibility Criteria
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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 bilateral middle ear effusion requiring tympanostomy tube placement
  • 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 prior ear or mastoid surgery, not including myringotomy or myringotomy with tympanostomy tube placement
  • Subject has a history of sensorineural hearing loss
  • Subject has been designated for any other surgical procedure that would occur concurrently with TT placement, such as, but not limited to adenoidectomy or tonsillectomy
Contacts and Locations
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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): NCT02350998


Locations
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United States, California
Central California Ear, Nose and Throat
Fresno, California, 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
Piedmont Ear, Nose and Throat
Winston-Salem, 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.
More Information
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Responsible Party: Otonomy, Inc.
ClinicalTrials.gov Identifier: NCT02350998    
Other Study ID Numbers: 201-201404
First Posted: January 30, 2015    Key Record Dates
Results First Posted: September 23, 2020
Last Update Posted: October 19, 2020
Last Verified: September 2020
Additional relevant MeSH terms:
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Otitis Media with Effusion
Otitis Media
Otitis
Ear Diseases
Otorhinolaryngologic Diseases