Phase 3 Study of OTO-201 in Acute Otitis Externa
Primary Purpose
Acute Otitis Externa, Swimmer's Ear
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
12 mg ciprofloxacin
Sham Control
Sponsored by
About this trial
This is an interventional treatment trial for Acute Otitis Externa
Eligibility Criteria
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
Sites / Locations
- Call Otonomy call center for trial locations
- Call Otonomy call center for trial locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
OTO-201
Control
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02801370
Brief Title
Phase 3 Study of OTO-201 in Acute Otitis Externa
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otonomy, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Otitis Externa, Swimmer's Ear
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
262 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OTO-201
Arm Type
Experimental
Arm Title
Control
Arm Type
Sham Comparator
Intervention Type
Drug
Intervention Name(s)
12 mg ciprofloxacin
Other Intervention Name(s)
OTIPRIO
Intervention Description
Single administration of OTO-201
Intervention Type
Drug
Intervention Name(s)
Sham Control
Intervention Description
Simulated, single adminstration
Primary Outcome Measure Information:
Title
Number of Subjects Considered a Clinical Cure at Day 8
Description
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
Time Frame
At Day 8 (1 week after dosing)
Secondary Outcome Measure Information:
Title
Number of Subjects Considered a Clinical Cure at Day 15
Description
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
Time Frame
At Day 15 (2 weeks after dosing)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carl LeBel, PhD
Organizational Affiliation
Otonomy, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Call Otonomy call center for trial locations
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
Facility Name
Call Otonomy call center for trial locations
City
Saskatoon
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Phase 3 Study of OTO-201 in Acute Otitis Externa
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