NCT02350998

Brief Summary

This is a 1-month, prospective, multicenter, open-label study in pediatric subjects with bilateral middle ear effusion requiring tympanostomy tube placement. Eligible subjects will receive a single dose to each ear of 6 mg OTO-201, administered intraoperatively into the middle ear through the lumen of the tympanostomy tube (trans-tympanostomy tube TTT). The study is designed to characterize safety and any procedural issues associated with TTT drug administration of OTO-201.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_3

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 30, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
5.6 years until next milestone

Results Posted

Study results publicly available

September 23, 2020

Completed
Last Updated

October 19, 2020

Status Verified

September 1, 2020

Enrollment Period

2 months

First QC Date

January 21, 2015

Results QC Date

September 1, 2020

Last Update Submit

September 24, 2020

Conditions

Bilateral Middle Ear Effusion

Outcome Measures

Primary Outcomes (3)

  • Otoscopic Examination: Auricle and Meatus

    Number of ears whose external ear and ear canal (auricle and meatus), when examined through an otoscope, appeared normal at Baseline and appeared abnormal at Day 29

    Up to 1 month

  • Otoscopic Examination: Tympanic Membrane

    Number of ears whose ear drum (tympanic membrane), when examined through an otoscope, appeared normal at Baseline and appeared abnormal at Day 29

    up to 1 month

  • Otoscopic Examination: Tube Patency

    Subjects with at least one ear tube patent (i.e., not blocked) at Day 29

    Up to 1 month

Secondary Outcomes (1)

  • Feasibility of Administration

    Day 1

Study Arms (1)

OTO-201

EXPERIMENTAL

6 mg OTO-201 administered trans-tympanostomy tube

Drug: OTO-201

Interventions

OTO-201DRUG
OTO-201

Eligibility Criteria

Age6 Months - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Subject is a male or female aged 6 months to 17 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 an attend all study visits

You may not qualify if:

  • 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 been designated for any other surgical procedure that would occur concurrently with TT placement, such as, but not limited to adenoidectomy or tonsillectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Central California Ear, Nose and Throat

Fresno, California, United States

Location

Charlotte Eye, Ear, Nose and Throat Associates

Charlotte, North Carolina, United States

Location

Charlotte Eye, Ear, Nose and Throat Associates

Matthews, North Carolina, United States

Location

Piedmont Ear, Nose and Throat

Winston-Salem, North Carolina, United States

Location

Carolina Ear, Nose and Throat

Orangeburg, South Carolina, United States

Location

Results Point of Contact

Title
Medical Information Call Center
Organization
Otonomy, Inc.
medinfo@otonomy.com
1-800-826-6411

Study Officials

  • Carl LeBel, PhD

    Otonomy, Inc.

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2015

First Posted

January 30, 2015

Study Start

January 1, 2015

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

October 19, 2020

Results First Posted

September 23, 2020

Record last verified: 2020-09

Locations

US(5)