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

Bilateral Middle Ear Effusion Requiring Tympanostomy Tube Placement Clinical Trial

Official title:

A Prospective, Randomized, Double-Blind, Sham-Controlled, Multicenter, Phase 3 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01949142
• Other study ID #: 201-201302
• Status: Completed
• Phase: Phase 3
• First received: September 20, 2013
• Last updated: August 17, 2015
• Start date: November 2013
• Est. completion date: May 2014

Study information

• Verified date: August 2015
• Source: Otonomy, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to confirm the effectiveness, safety and tolerability of OTO-201 in the treatment of pediatric subjects with bilateral middle ear effusion who require tympanostomy tube placement.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 266
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 12 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bilateral Middle Ear Effusion Requiring Tympanostomy Tube Placement
• Otitis Media with Effusion

Intervention

Drug:
• OTO-201
Single, intratympanic injection
• Sham
Simulated single, intratympanic injection

Locations

Country	Name	City	State
United States	Call/email Otonomy Central Contact for Trial Locations	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Otonomy, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy	Cumulative proportion of treatment failures	Up to 1 month	No
Secondary	Safety	Evaluation of adverse events, otoscopic exams, audiometry, and tympanometry	Up to 1 month	No
Secondary	Microbiological Response	Microbiological response through end of therapy and study	Up to 1 month	No