Skip to main content
OpenTrials
Completed

NCT Number: NCT02600559

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Otitis Media Ear Diseases Otitis Otorhinolaryngologic Diseases

Age range

6 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Email Otonomy Central Contact for Trial Locations

San Diego, California, 92121, United States

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 history of otitis media requiring bilateral 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 TT placement
  • Subject has been designated for any other surgical procedure that would occur concurrently with TT placement, except adenoidectomy, airway endoscopy, nasal endoscopy, and nasal cautery for epistaxis
  • Subject has a history of sensorineural hearing loss

Treatment and study plan

OTO-201 (ciprofloxacin)

Drug

Other names: OTIPRIO

Primary outcomes

  1. Number of Subjects With Post-surgical Otorrhea

    Time frame: Week 4

    Absence or presence of otorrhea (drainage from the middle ear)

  2. Number of Subjects With Post-surgical Otorrhea

    Time frame: 8 weeks

    Absence or presence of otorrhea (drainage from the middle ear)

Secondary outcomes

  1. Adverse Events

    Time frame: Up to Eight Weeks

    Evaluation of adverse events

  2. Caregiver Burden - Ear Discharge Control

    Time frame: Week 4

    Ear Drop Caregiver Burden Questionnaire at Week 4

  3. Caregiver Burden - Ear Discharge Control

    Time frame: Week 8

    Ear Drop Caregiver Burden Questionnaire at Week 8

  4. Caregiver Burden - Ear Drops Administration

    Time frame: Week 8

    Ear Drop Caregiver Burden Questionnaire at Week 8

Sponsors and collaborators

Lead sponsor

Otonomy, Inc.

Industry

Registry information

Official study 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 Tympanostomy Tubes

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 9, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.