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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

About this trial

This is an interventional treatment trial for Acute Otitis Externa

Eligibility Criteria

6 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

NCT ID

NCT02801370

First Posted

June 13, 2016

Last Updated

September 21, 2020

Sponsor

Otonomy, Inc.

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

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

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

Learn more about this trial

Phase 3 Study of OTO-201 in Acute Otitis Externa

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