Phase 2
N=95
Dose Ranging Study of OTO-201 in AOMT
Acute Otitis Media · AOMT
Bottom Line
View on ClinicalTrials.gov: NCT02719158 ↗Enrolled (actual)
95
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Number of Subjects With Adverse Events — 19; 14; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 6 mg ciprofloxacin (Drug); 12 mg ciprofloxacin (Drug); Sham (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Otonomy, Inc.
- Primary completion
- Jun 2016
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 | — |
Summary
Dose Ranging Study of OTO-201 in AOMT
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.