Phase 3
N=501
Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes
Otitis Media
Bottom Line
View on ClinicalTrials.gov: NCT02600559 ↗Enrolled (actual)
501
Serious AEs
0.2%
Results posted
Sep 2020
Primary outcome: Primary: Number of Subjects With Post-surgical Otorrhea — 383; 118 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- OTO-201 (ciprofloxacin) (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Otonomy, Inc.
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Post-surgical Otorrhea |
334; 167 | — |
| PRIMARY Number of Subjects With Post-surgical Otorrhea |
334; 167 | — |
| SECONDARY Adverse Events |
250; 251 | — |
| SECONDARY Caregiver Burden - Ear Discharge Control |
470; 5 | — |
| SECONDARY Caregiver Burden - Ear Discharge Control |
470; 5 | — |
| SECONDARY Caregiver Burden - Ear Drops Administration |
48; 23 | — |
Summary
This is an 8-week, multicenter, open-label study in which eligible subjects with a history of otitis media requiring TT placement will receive 6 mg OTO-201 to each ear. The study is designed to evaluate the safety and efficacy of OTO-201 in subjects undergoing TT placement with common concurrent surgeries and any middle ear effusion status.
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 history of otitis media requiring bilateral 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 TT placement
- Subject has been designated for any other surgical procedure that would occur concurrently with TT placement, except adenoidectomy, airway endoscopy, nasal endoscopy, and nasal cautery for epistaxis
- Subject has a history of sensorineural hearing loss
Data sourced from ClinicalTrials.gov (NCT02600559). 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.