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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official 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

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Otonomy, Inc.

Current Primary Outcome: 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.



Original Primary Outcome: Efficacy [ Time Frame: Up to 1 month ]

Cumulative proportion of treatment failures


Current Secondary Outcome:

  • 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.
  • Microbiological Response [ Time Frame: Day 15 - 2 weeks after dosing ]
    Subjects whose samples tested positive for bacteria in either or both ears.


Original Secondary Outcome:

  • Safety [ Time Frame: Up to 1 month ]
    Evaluation of adverse events, otoscopic exams, audiometry, and tympanometry
  • Microbiological Response [ Time Frame: Up to 1 month ]
    Microbiological response through end of therapy and study


Information By: Otonomy, Inc.

Dates:
Date Received: September 20, 2013
Date Started: November 2013
Date Completion:
Last Updated: May 9, 2016
Last Verified: May 2016