Phase 3 Study of OTO-201 in Acute Otitis Externa
Phase 3
Completed
- Conditions
- Acute Otitis ExternaSwimmer's Ear
- Interventions
- Drug: Sham Control
- Registration Number
- NCT02801370
- Lead Sponsor
- Otonomy, Inc.
- Brief Summary
This is a prospective, randomized, double-blind, sham-controlled, multicenter, Phase 3 study in which eligible subjects with acute otitis externa (AOE) will be randomized to receive a single administration of either 12 mg OTO-201 or Sham-Control (empty syringe) to the external auditory canal of the affected ear(s).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 262
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Control Sham Control - OTO-201 12 mg ciprofloxacin -
- Primary Outcome Measures
Name Time Method Number of Subjects Considered a Clinical Cure at Day 8 At Day 8 (1 week after dosing) Clinical Signs (edema, erythema, otorrhea and otalgia) all had a score of 0 at Day 15. Each sign was graded as follows:
None = 0 Mild = 1 Moderate = 2 Severe = 3
- Secondary Outcome Measures
Name Time Method Number of Subjects Considered a Clinical Cure at Day 15 At Day 15 (2 weeks after dosing) Clinical Signs (edema, erythema, otorrhea and otalgia) all had a score of 0 at Day 15. Each sign was graded as follows:
None = 0 Mild = 1 Moderate = 2 Severe = 3
Trial Locations
- Locations (1)
Call Otonomy call center for trial locations
đŸ‡¨đŸ‡¦Saskatoon, Canada