A Prospective, Randomized, Double-Blind, Sham-Controlled, Multicenter, Phase 3 Study of OTO-201 Given as a Single Administration for Treatment of Acute Otitis Externa
| Registry | NCT02801370 |
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| Status | Completed |
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| Phase | Phase 3 |
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| Study type | Interventional; randomized, single group, masking: triple, treatment |
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| Enrollment | 262 (Actual) |
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| Sponsor | Otonomy, Inc. (Industry) |
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| Conditions | Acute Otitis Externa, Swimmer's Ear |
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| Interventions | 12 mg ciprofloxacin, Sham Control (Drug) |
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| Dates | start 2016-06-01, primary completion 2016-11-01, completion 2016-12-01, first posted 2016-06-15, last updated 2020-10-19 |
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| Locations | 2 sites in United States, Canada |
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Related Papers Related Patents Related Grants Related Experts
All trials for Acute Otitis Externa All trials for Swimmer's Ear All trials of 12 mg ciprofloxacin All trials of Sham Control
-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).
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| OTO-201 | Experimental | Drug: 12 mg ciprofloxacin | |
| Control | Sham comparator | Drug: Sham Control | |
- 12 mg ciprofloxacin (Drug), also known as OTIPRIO: Single administration of OTO-201
- Sham Control (Drug): Simulated, single adminstration
+Outcome measures
Primary outcomes
- 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 outcomes
- 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
+Eligibility
Sex: All, ages: 6 Months to any
Inclusion Criteria includes, but is not limited to:
* Subject is a male or female age 6 months or older
* Subject has a clinical diagnosis of unilateral or bilateral acute otitis externa
* Subject or 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 tympanic membrane perforation
* Subject has eczematoid otitis externa
* Subject has diabetes mellitus
+Posted results
Participant flow
| Milestone | 12 mg OTO-201 | Control |
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| Started | 130 | 132 |
| Completed | 123 | 132 |
| Not completed | 7 | 0 |
Outcome results
- Number of Subjects Considered a Clinical Cure at Day 8 (Primary), Count of participants, Participants: 12 mg OTO-201 91; Control 63
- Number of Subjects Considered a Clinical Cure at Day 15 (Secondary), Count of participants, Participants: 12 mg OTO-201 97; Control 69
Adverse events
Time frame: Adverse events were reported during dosing and up to 1 month following dosing.
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|
| 12 mg OTO-201 | 0/127 (0.0%) | 0/127 (0.0%) | 12/127 (9.4%) |
| Control | 0/132 (0.0%) | 0/132 (0.0%) | 18/132 (13.6%) |
Other adverse events by term
| Term | Organ system | 12 mg OTO-201 | Control |
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| Otitis externa | Infections and infestations | 3/127 | 9/132 |
| Ear Pain | Ear and labyrinth disorders | 3/127 | 3/132 |
| Ear pruritis | Ear and labyrinth disorders | 3/127 | 2/132 |
| Erythema | Skin and subcutaneous tissue disorders | 0/127 | 3/132 |
| Headache | Nervous system disorders | 3/127 | 1/132 |
+Locations (2)
| Facility | City | Country | Status |
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| Call Otonomy call center for trial locations | San Diego, California | United States | |
| Call Otonomy call center for trial locations | Saskatoon | Canada | |
+Investigators