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Completed

NCT Number: NCT02719158

Dose Ranging Study of OTO-201 in AOMT

Dose Ranging Study of OTO-201 in AOMT

Completed

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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

Contact Otonomy call center for trial locations

San Diego, California, 92121, United States

About this study

This is a 1-month, prospective, multicenter, randomized, dose-ranging, sham-controlled, blinded study in which eligible subjects with either unilateral or bilateral acute otitis media with tympanostomy tubes (AOMT) will receive a single administration of 6 mg OTO-201, 12 mg OTO-201, or sham into the affected ear(s).

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

6 mg ciprofloxacin

Drug

Single administration of OTO-201

Other names: OTIPRIO

12 mg ciprofloxacin

Drug

Single administration of OTO-201

Other names: OTIPRIO

SHAM

Other

Primary outcomes

  1. Number of Subjects With Adverse Events

    Time frame: Up to 1 month

    Number of subjects with adverse events during the study from dosing up to 1 month after dosing

  2. Otoscopic Examination: Auricle and Meatus

    Time frame: Up to 1 month

    Number of affected ears (i.e., those ears that were infected) whose external ear and ear canal (auricle and meatus), when examined through an otoscope, appeared normal at Baseline and appeared abnormal at Day 29. The auricle and meatus of each infected ear was examined using an otoscope and was assessed as either normal or abnormal at every visit. This outcome looks to see if there was a worsening of the condition of the auricle and meatus with treatment (i.e., a safety measure).

  3. Otoscopic Examination: Tympanic Membrane

    Time frame: Up to 1 month

    Number of affected ears (i.e., those ears that were infected) whose ear drum (tympanic membrane), when examined through an otoscope, appeared normal at Baseline and appeared abnormal at Day 29. The tympanic membrane of each infected ear was examined using an otoscope and was assessed as either normal or abnormal at every visit. This outcome looks to see if there was a worsening of the condition of the tympanic membrane with treatment (i.e., a safety measure).

Secondary outcomes

  1. Absence of Otorrhea

    Time frame: Up to Two Weeks

    Absence of otorrhea (middle ear drainage)

Sponsors and collaborators

Lead sponsor

Otonomy, Inc.

Industry

Registry information

Official study title

A 1-Month, Prospective, Multicenter, Randomized, Dose-Ranging, Sham-Controlled, Blinded Study of OTO-201 Given as a Single Administration for Treatment of Acute Otitis Media With Tympanostomy Tubes in Pediatric Subjects

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 25, 2016
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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