Dose Ranging Study of OTO-201 in AOMT

Phase 2CompletedNCT02719158

Otonomy, Inc.95 enrolled

Overview

This is a 1-month, prospective, multicenter, randomized, dose-ranging, sham-controlled, blinded study in which eligible subjects with either unilateral or bilateral acute otitis media with tympanostomy tubes (AOMT) will receive a single administration of 6 mg OTO-201, 12 mg OTO-201, or sham into the affected ear(s).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Acute Otitis Media AOMT

Interventions

6 mg ciprofloxacinDRUG

Single administration of OTO-201

12 mg ciprofloxacinDRUG

Single administration of OTO-201

ShamOTHER

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria includes, but is not limited to: * 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 Exclusion Criteria includes, but is not limited to: * 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

Locations (1)

Contact Otonomy call center for trial locations

San Diego, California, United States

Outcomes

Primary Outcomes

Number of Subjects With Adverse Events

Number of subjects with adverse events during the study from dosing up to 1 month after dosing

Time frame: Up to 1 month

Otoscopic Examination: Auricle and Meatus

Number of affected ears (i.e., those ears that were infected) whose external ear and ear canal (auricle and meatus), when examined through an otoscope, appeared normal at Baseline and appeared abnormal at Day 29. The auricle and meatus of each infected ear was examined using an otoscope and was assessed as either normal or abnormal at every visit. This outcome looks to see if there was a worsening of the condition of the auricle and meatus with treatment (i.e., a safety measure).

Time frame: Up to 1 month

Otoscopic Examination: Tympanic Membrane

Number of affected ears (i.e., those ears that were infected) whose ear drum (tympanic membrane), when examined through an otoscope, appeared normal at Baseline and appeared abnormal at Day 29. The tympanic membrane of each infected ear was examined using an otoscope and was assessed as either normal or abnormal at every visit. This outcome looks to see if there was a worsening of the condition of the tympanic membrane with treatment (i.e., a safety measure).

Time frame: Up to 1 month

Secondary Outcomes

Absence of Otorrhea

Absence of otorrhea (middle ear drainage)

Time frame: Up to Two Weeks

Data from ClinicalTrials.gov

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