Clinical trial NCT01949155: OTO-201 for the Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Otitis Media With Effusion
Keywords: otitis media
otorrhea
middle ear effusion
tympanostomy tubes
Lead sponsor: Otonomy, Inc.
Sponsor class: INDUSTRY
First posted: 2013-09-24
Enrollment: 266
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Percentage of Participants Who Were Treatment Failures.
timeFrame: Day 15 - 2 weeks after dosing
Secondary outcomes:
measure: Evaluation of Adverse Events, Otoscopic Exams, Audiometry and Tympanometry
timeFrame: Up to one month
measure: Microbiological Response
timeFrame: Day 15 - 2 weeks after dosing
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Call/email Otonomy Central Contact for Trial Locations
state: California
Study officials:
affiliation: Otonomy, Inc.
name: Carl LeBel, PhD
role: STUDY_DIRECTOR
References:
citation: 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.