OTO-201 for 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, 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01755286
• Other study ID #: 201-201101
• Status: Completed
• Phase: Phase 1
• First received: December 18, 2012
• Last updated: June 17, 2013
• Start date: December 2012
• Est. completion date: June 2013

Study information

• Verified date: June 2013
• Source: Otonomy, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• 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 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 intra-operative injection
• Placebo
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	Safety	Evaluation of adverse events, otoscopic exams, audiometry, and tympanometry	Up to 1 month	Yes
Secondary	Clinical Activity	Evaluation of physician reported and caregiver reported otorrhea	Up to 1 month	No
Secondary	Microbiological Eradication	Microbiological eradication of pretherapy bacteria	Up to 1 month	No