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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01949142
Recruitment Status : Completed
First Posted : September 24, 2013
Results First Posted : June 15, 2016
Last Update Posted : June 15, 2016
Sponsor:
Information provided by (Responsible Party):
Otonomy, Inc.

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.

Condition or disease Intervention/treatment Phase
Otitis Media With Effusion Drug: OTO-201 Drug: Sham Phase 3

Detailed Description:

This is a prospective, randomized, double-blind, sham-controlled, multicenter, Phase 3 study of OTO-201 administered intraoperatively in pediatric subjects with bilateral middle ear effusion requiring TT (tympanostomy tube) placement. One dose level (6 mg) of OTO-201 was evaluated relative to sham (empty syringe).

Study subjects are required to have a clinical diagnosis of bilateral middle ear effusion requiring TT placement. On the day of surgery, prior to surgery, eligible subjects were examined via otoscope to confirm bilateral middle ear effusion. Subjects with bilateral middle ear effusion were randomized to either 6 mg OTO-201 or sham. Subjects without bilateral effusion on the day of surgery were not randomized and were considered screen failures.

Approximately 264 subjects are planned to be randomized to OTO-201 or sham using a 2:1 allocation ratio. Randomization to OTO-201 or sham was stratified by age: 6 months to 2 years or >2 years.

Subjects are to visit the study site for safety assessments and otoscopic examination on Days 4, 8, 15, and 29. The assessment of otorrhea by the blinded assessor for the primary efficacy endpoint occurred on Days 4, 8, and 15.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 266 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective, Randomized, Double-Blind, Sham-Controlled, Multicenter, P3 Study of OTO-201 Given as a Single IT Injection For Intra-Operative Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement
Study Start Date : November 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections

Arm Intervention/treatment
Experimental: OTO-201

OTO-201: Single, intratympanic injection:

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

Drug: OTO-201
Single, intratympanic injection

Sham Comparator: Sham

Sham: Simulated single, intratympanic injection:

One sham injection into each ear during surgery.

Drug: Sham
Simulated single, intratympanic injection




Primary Outcome Measures :
  1. Percentage of Participants Who Were Treatment Failures [ Time Frame: Day 15 - 2 weeks after dosing ]

    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.



Secondary Outcome Measures :
  1. Evaluation of Adverse Events, Otoscopic Exams, Audiometry, and Tympanometry [ Time Frame: Up to one month ]
    Safety variables included the frequency of adverse events (AEs) and results from otoscopic examinations, tympanometry, audiometry, vital sign measurements, and physical examinations.

  2. Microbiological Response [ Time Frame: Day 15 - 2 weeks after dosing ]
    Subjects whose samples tested positive for bacteria in either or both ears.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria includes, but is not limited to:

  • 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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01949142


Locations
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United States, California
Call/email Otonomy Central Contact for Trial Locations
San Diego, California, United States, 92121
Sponsors and Collaborators
Otonomy, Inc.
Investigators
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Study Director: Carl LeBel, PhD Otonomy, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Otonomy, Inc.
ClinicalTrials.gov Identifier: NCT01949142    
Other Study ID Numbers: 201-201302
First Posted: September 24, 2013    Key Record Dates
Results First Posted: June 15, 2016
Last Update Posted: June 15, 2016
Last Verified: May 2016
Keywords provided by Otonomy, Inc.:
otitis media
otorrhea
middle ear effusion
tympanostomy tubes
Additional relevant MeSH terms:
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Otitis
Otitis Media
Otitis Media with Effusion
Ear Diseases
Otorhinolaryngologic Diseases