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

Phase 2

Completed

• Conditions: Acute Otitis Media; AOMT
• Interventions: Drug: OTO-201

• Registration Number: NCT02408796
• Lead Sponsor: Otonomy, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-27
• Study First Submitted QC: 2015-04-02
• Study First Posted: 2015-04-03
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2020-09
• Results First Submitted: 2020-09-01
• Results First Submitted QC: 2020-09-01
• Results First Posted: 2020-09-23
• Last Update Submitted: 2020-09-24
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OTO-201	OTO-201	6 mg OTO-201

Primary Outcome Measures

Name	Time	Method
Feasibility of Administration Questionnaire	Day 1	Issues Administering OTO-201 onto the Tympanic Membrane and the Auditory Canal-facing Side of the Tympanostomy Tube (answered "yes")
Number of Ears With Otorrhea (Drainage From the Middle Ear)	Day 29	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.

Secondary Outcome Measures

Name	Time	Method
Number of Ears With no More Otorrhea (Drainage From the Middle Ear)	Day 15	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 15 days after administering OTO-201 to see if it worked and there is no more drainage from the middle ear.

Trial Locations

Locations (4)

South Florida Pediatric Otolaryngology; 🇺🇸 Fort Lauderdale, Florida, United States

Carolina Ear, Nose and Throat; 🇺🇸 Orangeburg, South Carolina, United States

Central California Ear, Nose and Throat; 🇺🇸 Fresno, California, United States

Charlotte Eye, Ear, Nose and Throat Associates; 🇺🇸 Matthews, North Carolina, United States