OTO-201 for Middle Ear Effusion in Pediatric Subjects Req... | NCT01755286

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

NCT01755286

Sponsor

Otonomy, Inc.

Status

Completed

Last Update Posted

Jun 19, 2013Estimated

Enrollment

83Actual

Phase

Phase 1

Conditions

Bilateral Middle Ear Effusion Requiring Tympanostomy Tube Placement

Interventions

OTO-201
Placebo
Sham

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

Jun 2013Actual

Completion Date

Jun 2013Actual

First Submitted Date

Dec 18, 2012

First Submission Date that Met QC Criteria

Dec 18, 2012

First Posted Date

Dec 24, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 17, 2013

Last Update Posted Date

Jun 19, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

83Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
4 mg OTO-201	Experimental	Drug: OTO-201
12 mg OTO-201	Experimental	Drug: OTO-201
Vehicle for OTO-201	Placebo Comparator	Drug: Placebo
Sham	Sham Comparator	Drug: Sham

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OTO-201	Drug	Single intra-operative injection	12 mg OTO-201 4 mg OTO-201

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carl LeBel, PhD	Otonomy, Inc.	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Call/Email Otonomy Central Contact for Trial Locations		San Diego	California	92121	United States

Intervention Browse Module

MeSH Terms

ID	Term
D002939	Ciprofloxacin
C005703	salicylhydroxamic acid

Ancestor Terms

ID	Term
D024841	Fluoroquinolones
D042462	4-Quinolones
D015363	Quinolones
D011804	Quinolines

Browse Leaves

Not provided

Browse Branches

Not provided