OTO-201 for 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: | 5/27/2013 |
| Start Date: | December 2012 |
| End Date: | August 2013 |
| Contact: | Liza Wallace |
| Email: | LWallace@Otonomy.com |
| Phone: | 858-242-5200 |
A Prospective, Randomized, Double-Blind, Placebo- and Sham-Controlled, Multicenter, Phase 1b 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 describe the safety and tolerability of two dose levels of
OTO-201, placebo and sham when administered intra-operatively in 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
We found this trial at
1
site
Click here to add this to my saved trials
