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OpenTrials
Completed

NCT Number: NCT02408796

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

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.

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Key information

Conditions

Acute Otitis Media AOMT Ear Diseases Otitis Otitis Media Otorhinolaryngologic Diseases

Age range

6 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Central California Ear, Nose and Throat, Fresno, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OTO-201

Drug

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Otonomy, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 3, 2015
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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