Acute Otitis Externa Clinical Trial
Official title:
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
NCT number | NCT02801370 |
Other study ID # | 201-201609 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | June 2016 |
Est. completion date | December 2016 |
Verified date | September 2020 |
Source | Otonomy, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 262 |
Est. completion date | December 2016 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Call Otonomy call center for trial locations | Saskatoon | |
United States | Call Otonomy call center for trial locations | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
Otonomy, Inc. |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Subjects Considered a Clinical Cure at Day 8 | 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 |
At Day 8 (1 week after dosing) | |
Secondary | Number of Subjects Considered a Clinical Cure at Day 15 | 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 |
At Day 15 (2 weeks after dosing) |
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