Phase 3 Study of OTO-201 in Acute Otitis Externa

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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Key information

Conditions

Acute Otitis Externa Ear Diseases Otitis Otitis Externa Otorhinolaryngologic Diseases Swimmer's Ear

Age range

6 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Call Otonomy call center for trial locations, Saskatoon, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

12 mg ciprofloxacin

Drug

Single administration of OTO-201

Other names: OTIPRIO

Sham Control

Drug

Simulated, single adminstration

Primary outcomes

Number of Subjects Considered a Clinical Cure at Day 8

Time frame: 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

Time frame: 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

Sponsors and collaborators

Lead sponsor

Otonomy, Inc.

Industry

Registry information

Official study 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

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2016
First posted: Jun 15, 2016
Registry last updated: Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed