OTO-201 for the Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement
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|ClinicalTrials.gov Identifier: NCT01949155|
Recruitment Status : Completed
First Posted : September 24, 2013
Results First Posted : November 11, 2016
Last Update Posted : November 11, 2016
|Condition or disease||Intervention/treatment||Phase|
|Otitis Media With Effusion||Drug: OTO-201 Drug: Sham||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||266 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|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 :||May 2014|
OTO-201: Single, intratympanic injection:
One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery.
Single, intratympanic injection
Sham Comparator: Sham
Sham: Simulated single, intratympanic injection:
One sham injection into each ear during surgery.
Simulated single, intratympanic injection
- 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.
- 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 measurements.
- Microbiological Response [ Time Frame: Day 15 - 2 weeks after dosing ]Subjects whose samples tested positive for bacteria in either or both ears at baseline with documented eradication or presumed eradication post-baseline.
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): NCT01949155
|United States, California|
|Call/email Otonomy Central Contact for Trial Locations|
|San Diego, California, United States, 92121|
|Study Director:||Carl LeBel, PhD||Otonomy, Inc.|