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Completed

NCT Number: NCT01949142

OTO-201 for the Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement

The purpose of this study is to confirm the effectiveness, safety and tolerability of OTO-201 in the treatment of pediatric subjects with bilateral middle ear effusion who require tympanostomy tube placement.

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Key information

Conditions

OTITIS MEDIA WITH EFFUSION Ear Diseases Otitis Otitis Media Otorhinolaryngologic Diseases

Age range

6 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Call/email Otonomy Central Contact for Trial Locations

San Diego, California, 92121, United States

About this study

This is a prospective, randomized, double-blind, sham-controlled, multicenter, Phase 3 study of OTO-201 administered intraoperatively in pediatric subjects with bilateral middle ear effusion requiring TT (tympanostomy tube) placement. One dose level (6 mg) of OTO-201 was evaluated relative to sham (empty syringe).

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.

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 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

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 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

Treatment and study plan

OTO-201

Drug

Single, intratympanic injection

sham

Drug

Simulated single, intratympanic injection

Primary outcomes

  1. Percentage of Participants Who Were Treatment Failures

    Time frame: Day 15 - 2 weeks after dosing

    Cumulative proportion of treatment failures:

    The efficacy endpoint for both trials was the cumulative proportion of study treatment failures through Day 15, defined as the occurrence of any of the following events: otorrhea as determined by a blinded assessor on or after 3 days post-surgery, otic or systemic antibacterial drug use for any reason any time post-surgery, as well as patients who missed visits or were lost-to-follow-up.

Secondary outcomes

  1. Evaluation of Adverse Events, Otoscopic Exams, Audiometry, and Tympanometry

    Time frame: Up to one month

    Safety variables included the frequency of adverse events (AEs) and results from otoscopic examinations, tympanometry, audiometry, vital sign measurements, and physical examinations.

  2. Microbiological Response

    Time frame: Day 15 - 2 weeks after dosing

    Subjects whose samples tested positive for bacteria in either or both ears.

Sponsors and collaborators

Lead sponsor

Otonomy, Inc.

Industry

Registry information

Official study title

Prospective, Randomized, Double-Blind, Sham-Controlled, Multicenter, P3 Study of OTO-201 Given as a Single IT Injection For Intra-Operative Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 24, 2013
Registry last updated
Jun 15, 2016

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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