NCT01949142

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
266

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2013

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

September 20, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 24, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
2 years until next milestone

Results Posted

Study results publicly available

June 15, 2016

Completed
Last Updated

June 15, 2016

Status Verified

May 1, 2016

Enrollment Period

6 months

First QC Date

September 20, 2013

Results QC Date

January 27, 2016

Last Update Submit

May 9, 2016

Conditions

Otitis Media With Effusion

Keywords

otitis mediaotorrheamiddle ear effusiontympanostomy tubes

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Who Were Treatment Failures

    Cumulative proportion of treatment failures: The efficacy endpoint for both trials was the cumulative proportion of study treatment failures through Day 15, defined as the occurrence of any of the following events: otorrhea as determined by a blinded assessor on or after 3 days post-surgery, otic or systemic antibacterial drug use for any reason any time post-surgery, as well as patients who missed visits or were lost-to-follow-up.

    Day 15 - 2 weeks after dosing

Secondary Outcomes (2)

  • Evaluation of Adverse Events, Otoscopic Exams, Audiometry, and Tympanometry

    Up to one month

  • Microbiological Response

    Day 15 - 2 weeks after dosing

Study Arms (2)

OTO-201

EXPERIMENTAL

OTO-201: Single, intratympanic injection: One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery.

Drug: OTO-201

Sham

SHAM COMPARATOR

Sham: Simulated single, intratympanic injection: One sham injection into each ear during surgery.

Drug: Sham

Interventions

OTO-201DRUG

Single, intratympanic injection

OTO-201
ShamDRUG

Simulated single, intratympanic injection

Sham

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 and 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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Call/email Otonomy Central Contact for Trial Locations

San Diego, California, 92121, United States

Location

Related Publications (1)

  • Mair EA, Park AH, Don D, Koempel J, Bear M, LeBel C. Safety and Efficacy of Intratympanic Ciprofloxacin Otic Suspension in Children With Middle Ear Effusion Undergoing Tympanostomy Tube Placement: Two Randomized Clinical Trials. JAMA Otolaryngol Head Neck Surg. 2016 May 1;142(5):444-51. doi: 10.1001/jamaoto.2016.0001.

    PMID: 26985629DERIVED

MeSH Terms

Conditions

Otitis Media with EffusionOtitis Media

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

OtitisEar DiseasesOtorhinolaryngologic Diseases

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 DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2013

First Posted

September 24, 2013

Study Start

November 1, 2013

Primary Completion

May 1, 2014

Study Completion

June 1, 2014

Last Updated

June 15, 2016

Results First Posted

June 15, 2016

Record last verified: 2016-05

Locations

US(1)