OTO-201 for Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement

A Prospective, Randomized, Double-Blind, Placebo- and Sham-Controlled, Multicenter, Phase 1b Study of OTO-201 Given as a Single Intratympanic Injection for Intra-Operative Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement

The purpose of this study is to describe the safety and tolerability of two dose levels of OTO-201, placebo and sham when administered intra-operatively in pediatric subjects with bilateral middle ear effusion who require tympanostomy tube placement.

Study Overview

• Status: Completed
• Conditions: Bilateral Middle Ear Effusion Requiring Tympanostomy Tube Placement
• Intervention / Treatment: Drug: Placebo; Drug: OTO-201; Drug: Sham

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92121
      • Call/email Otonomy Central Contact for Trial Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 12 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 12 years, inclusive
• Subject has a clinical diagnosis of bilateral middle ear effusion requiring 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 tympanostomy tube placement
• Subject has a history of sensorineural hearing loss
• Subject has a history of chronic or recurrent bacterial infections other than otitis media that likely will require treatment with antibiotics during the course of the study

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham	Drug: Sham; Simulated single intratympanic injection
Experimental: 4 mg OTO-201	Drug: OTO-201; Single intra-operative injection; Other Names: ciprofloxacin
Experimental: 12 mg OTO-201	Drug: OTO-201; Single intra-operative injection; Other Names: ciprofloxacin
Placebo Comparator: Vehicle for OTO-201	Drug: Placebo; Single intratympanic injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	Evaluation of adverse events, otoscopic exams, audiometry, and tympanometry	Up to 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Activity	Evaluation of physician reported and caregiver reported otorrhea	Up to 1 month
Microbiological Eradication	Microbiological eradication of pretherapy bacteria	Up to 1 month

Collaborators and Investigators

• Sponsor: Otonomy, Inc.

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: December 18, 2012
• First Submitted That Met QC Criteria: December 18, 2012
• First Posted (Estimate): December 24, 2012

Study Record Updates

• Last Update Posted (Estimate): June 19, 2013
• Last Update Submitted That Met QC Criteria: June 17, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otitis; Otitis Media; Otitis Media with Effusion; 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: 201-201101