Phase 3 Study of OTO-201 in Acute Otitis Externa
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
1 other identifier
interventional
262
2 countries
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2016
Shorter than P25 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 13, 2016
CompletedFirst Posted
Study publicly available on registry
June 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedResults Posted
Study results publicly available
September 22, 2020
CompletedOctober 19, 2020
September 1, 2020
5 months
June 13, 2016
September 1, 2020
September 21, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Number of Subjects Considered a Clinical Cure at Day 15
At Day 15 (2 weeks after dosing)
Study Arms (2)
OTO-201
EXPERIMENTALControl
SHAM COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Subject has tympanic membrane perforation
- Subject has eczematoid otitis externa
- Subject has diabetes mellitus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Otonomy, Inc.lead
Study Sites (2)
Call Otonomy call center for trial locations
San Diego, California, 92121, United States
Call Otonomy call center for trial locations
Saskatoon, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Information Call Center
- Organization
- Otonomy
Study Officials
- STUDY CHAIR
Carl LeBel, PhD
Otonomy, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2016
First Posted
June 15, 2016
Study Start
June 1, 2016
Primary Completion
November 1, 2016
Study Completion
December 1, 2016
Last Updated
October 19, 2020
Results First Posted
September 22, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share