Open-Label Study of OTO-201 for Treatment of AOMT

NCT02408796 | Completed Phase 2 Results

• 1 other identifier: 201-201505
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 5

Brief Summary

This is a 1-month, prospective, multicenter, open-label study in pediatric subjects with either unilateral or bilateral acute otitis media with tympanostomy tubes (AOMT). Eligible subjects will receive a single dose of 6 mg OTO-201 to the affected ear(s). The study is designed to characterize safety, procedural factors and clinical effect of OTO-201 administered in subjects with AOMT.

Conditions

Acute Otitis Media; AOMT

Keywords

Acute otitis media with tympanostomy tubes

Outcome Measures

Primary Outcomes (2)

• Number of Ears With Otorrhea (Drainage From the Middle Ear)

  Acute otitis media with tympanostomy tubes in place (AOMT) refers to subjects that have ear tubes present, but have a middle ear infection. Otorrhea is fluid drainage from the middle ear. This outcome is assessed during the otoscopic examination of each affected ear (the ear with the infection). All subjects have otorrhea in the affected ear at Baseline and the assessment is done after administering OTO-201 to be sure there is no infection remaining or no new infection.

  Day 29

• Feasibility of Administration Questionnaire

  Issues Administering OTO-201 onto the Tympanic Membrane and the Auditory Canal-facing Side of the Tympanostomy Tube (answered "yes")

  Day 1

Secondary Outcomes (1)

• Number of Ears With no More Otorrhea (Drainage From the Middle Ear)

  Day 15

Study Arms (1)

OTO-201

EXPERIMENTAL

6 mg OTO-201

Drug: OTO-201

Interventions

OTO-201 DRUG

OTO-201

Eligibility Criteria

• Age: 6 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Otonomy, Inc.: lead

Study Sites (5)

Central California Ear, Nose and Throat

Fresno, California, United States

Location

South Florida Pediatric Otolaryngology

Fort Lauderdale, Florida, United States

Location

Charlotte Eye, Ear, Nose and Throat Associates

Charlotte, North Carolina, United States

Location

Charlotte Eye, Ear, Nose and Throat Associates

Matthews, North Carolina, United States

Location

Carolina Ear, Nose and Throat

Orangeburg, South Carolina, United States

Location

MeSH Terms

Conditions

Otitis Media

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Results Point of Contact

• Title: Medical Information Call Center
• Organization: Otonomy, Inc.

medinfo@otonomy.com

1-800-826-6411

Study Officials

• Carl LeBel, PhD

  Otonomy, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2015
• First Posted: April 3, 2015
• Study Start: March 1, 2015
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: October 19, 2020
• Results First Posted: September 23, 2020

Record last verified: 2020-09

Locations

US (5)