OTO-201 for the Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any - 12 |
| Updated: | 4/21/2016 |
| Start Date: | November 2013 |
| End Date: | May 2014 |
A Prospective, Randomized, Double-Blind, Sham-Controlled, Multicenter, Phase 3 Study of OTO-201 Given as a Single Intratympanic Injection For Intra-Operative Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement
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.
OTO-201 in the treatment of pediatric subjects with bilateral middle ear effusion who
require tympanostomy tube placement.
Inclusion Criteria includes, but is not limited to:
- Subject is a male or female aged 6 months to 12 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
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