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

Primary Purpose

Bilateral Middle Ear Effusion Requiring Tympanostomy Tube Placement

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

OTO-201

Placebo

Sham

About this trial

This is an interventional treatment trial for Bilateral Middle Ear Effusion Requiring Tympanostomy Tube Placement

Eligibility Criteria

6 Months - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Call/Email Otonomy Central Contact for Trial Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Sham Comparator

Arm Label

4 mg OTO-201

12 mg OTO-201

Vehicle for OTO-201

Sham

Arm Description

Outcomes

Primary Outcome Measures

Safety

Evaluation of adverse events, otoscopic exams, audiometry, and tympanometry

Secondary Outcome Measures

Clinical Activity

Evaluation of physician reported and caregiver reported otorrhea

Microbiological Eradication

Microbiological eradication of pretherapy bacteria

Full Information

NCT ID

NCT01755286

First Posted

December 18, 2012

Last Updated

June 17, 2013

Sponsor

Otonomy, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01755286

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Completed

Study Start Date

December 2012 (undefined)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Otonomy, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bilateral Middle Ear Effusion Requiring Tympanostomy Tube Placement

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

83 (Actual)

8. Arms, Groups, and Interventions

Arm Title

4 mg OTO-201

Arm Type

Experimental

Arm Title

12 mg OTO-201

Arm Type

Experimental

Arm Title

Vehicle for OTO-201

Arm Type

Placebo Comparator

Arm Title

Sham

Arm Type

Sham Comparator

Intervention Type

Drug

Intervention Name(s)

OTO-201

Other Intervention Name(s)

ciprofloxacin

Intervention Description

Single intra-operative injection

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Single intratympanic injection

Intervention Type

Drug

Intervention Name(s)

Sham

Intervention Description

Simulated single intratympanic injection

Primary Outcome Measure Information:

Title

Safety

Description

Evaluation of adverse events, otoscopic exams, audiometry, and tympanometry

Time Frame

Up to 1 month

Secondary Outcome Measure Information:

Title

Clinical Activity

Description

Evaluation of physician reported and caregiver reported otorrhea

Time Frame

Up to 1 month

Title

Microbiological Eradication

Description

Microbiological eradication of pretherapy bacteria

Time Frame

Up to 1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carl LeBel, PhD

Organizational Affiliation

Otonomy, Inc.

Official's Role

Study Chair

Facility Information:

Facility Name

Call/Email Otonomy Central Contact for Trial Locations

City

San Diego

State/Province

California

ZIP/Postal Code

92121

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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