Dose Ranging Study of OTO-201 in AOMT

A 1-Month, Prospective, Multicenter, Randomized, Dose-Ranging, Sham-Controlled, Blinded Study of OTO-201 Given as a Single Administration for Treatment of Acute Otitis Media With Tympanostomy Tubes in Pediatric Subjects

Dose Ranging Study of OTO-201 in AOMT

Study Overview

• Status: Completed
• Conditions: Acute Otitis Media; AOMT
• Intervention / Treatment: Other: Sham; Drug: 6 mg ciprofloxacin; Drug: 12 mg ciprofloxacin

Detailed Description

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
• Enrollment (Actual): 95
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92121
      • Contact Otonomy call center for trial locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 6 mg OTO-201; 6 mg OTO-201 (sustained-release suspension of ciprofloxacin), single 0.1 mL supra-tympanostomy tube (STT) administration to the affected ear(s)	Drug: 6 mg ciprofloxacin; Single administration of OTO-201; Other Names: OTIPRIO
Experimental: 12 mg OTO-201; 12 mg OTO-201 (sustained-release suspension of ciprofloxacin), single 0.2 mL supra-tympanostomy tube (STT) administration to the affected ear(s)	Drug: 12 mg ciprofloxacin; Single administration of OTO-201; Other Names: OTIPRIO
Sham Comparator: Sham (empty syringe); Sham (empty syringe), single 0.1 mL STT administration to the affected ear(s)	Other: Sham

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Adverse Events	Number of subjects with adverse events during the study from dosing up to 1 month after dosing	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).	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).	Up to 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absence of Otorrhea	Absence of otorrhea (middle ear drainage)	Up to Two Weeks

Collaborators and Investigators

• Sponsor: Otonomy, Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: March 21, 2016
• First Submitted That Met QC Criteria: March 21, 2016
• First Posted (Estimate): March 25, 2016

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: September 24, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Acute otitis media with tympanostomy tubes; OTIPRIO
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otitis; Otitis Media; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Ciprofloxacin
• Other Study ID Numbers: 201-201508