Clinical Trial: Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes

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

Official Title: An 8-Week, Prospective, Multicenter, Open-Label Study of OTO-201 Given as a Single Administration in Pediatric Subjects With a History of Otitis Media Requiring Tympanosto

Brief Summary: This is an 8-week, multicenter, open-label study in which eligible subjects with a history of otitis media requiring TT placement will receive 6 mg OTO-201 to each ear. The study is designed to evaluate the safety and efficacy of OTO-201 in subjects undergoing TT placement with common concurrent surgeries and any middle ear effusion status.

Detailed Summary:
Sponsor: Otonomy, Inc.

Current Primary Outcome: Post-surgical otorrhea [ Time Frame: Up to Eight Weeks ]

Absence/presence of otorrhea


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Safety as assessed by adverse events [ Time Frame: Up to Eight Weeks ]
    Evaluation of adverse events
  • Caregiver burden as assessed by the Ear Drop Caregiver Burden Questionnaire [ Time Frame: Up to Eight Weeks ]
    Questionnaire


Original Secondary Outcome: Same as current

Information By: Otonomy, Inc.

Dates:
Date Received: November 5, 2015
Date Started: October 2015
Date Completion:
Last Updated: July 26, 2016
Last Verified: July 2016