Phase 2
Completed N=95
Dose Ranging Study of OTO-201 in AOMT
Acute otitis media · AOMT
Source: ClinicalTrials.gov NCT02719158 ↗
Enrolled (actual)
95
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcomePrimary: Number of Subjects With Adverse Events — 19; 14; 4 Participants
Summary
Dose Ranging Study of OTO-201 in AOMT
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Adverse Events |
19; 14; 4 | — |
| PRIMARY Otoscopic Examination: Auricle and Meatus |
2; 0; 0 | — |
| PRIMARY Otoscopic Examination: Tympanic Membrane |
1; 0; 0 | — |
| SECONDARY Absence of Otorrhea |
20; 23; 2 | — |
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 (NCT02719158). 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.