Phase 2
Completed N=39
Open-Label Study of OTO-201 for Treatment of AOMT
Acute otitis media · AOMT
Source: ClinicalTrials.gov NCT02408796 ↗
Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcomePrimary: Number of Ears With Otorrhea (Drainage From the Middle Ear) — 8 affected ears
Summary
This is a 1-month, prospective, multicenter, open-label study in pediatric subjects with either unilateral or bilateral acute otitis media with tympanostomy tubes (AOMT). Eligible subjects will receive a single dose of 6 mg OTO-201 to the affected ear(s). The study is designed to characterize safety, procedural factors and clinical effect of OTO-201 administered in subjects with AOMT.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Ears With Otorrhea (Drainage From the Middle Ear) |
8 | — |
| PRIMARY Feasibility of Administration Questionnaire |
2 | — |
| SECONDARY Number of Ears With no More Otorrhea (Drainage From the Middle Ear) |
50 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT02408796). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.