Dose Ranging Study of OTO-201 in AOMT
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Infectious Disease, Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases, Other |
| Healthy: | No |
| Age Range: | Any - 17 |
| Updated: | 8/3/2016 |
| Start Date: | February 2016 |
| End Date: | July 2016 |
A 1-Month, Prospective, Multicenter, Randomized, Dose-Ranging, Sham-Controlled, Blinded Study of OTO-201 Given as a Single Administration for Treatment of Acute Otitis Media With Tympanostomy Tubes in Pediatric Subjects
This is a 1-month, prospective, multicenter, randomized, dose-ranging, sham-controlled,
blinded study in which eligible subjects with either unilateral or bilateral acute otitis
media with tympanostomy tubes (AOMT) will receive a single administration of 6 mg OTO-201,
12 mg OTO-201, or sham into the affected ear(s).
blinded study in which eligible subjects with either unilateral or bilateral acute otitis
media with tympanostomy tubes (AOMT) will receive a single administration of 6 mg OTO-201,
12 mg OTO-201, or sham into the affected ear(s).
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 acute otitis media with tympanostomy tubes (AOMT)
- Subject's caregiver is willing to comply with the protocol an attend all study visits
Exclusion Criteria includes, but is not limited to:
- Subject has a history of sensorineural hearing loss
- Subject has tympanic membrane perforation other than the surgical tympanostomy tube
perforation
- Subject has a history of known immunodeficiency disease
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