A Phase III, Multicenter, Randomized, Double-Blind Clinical Trial to Assess the Efficacy and Safety of DF289 Plus DF277 Otic Solution Compared to DF289 Otic Solution and to DF277 Otic Solution in the Treatment of Acute Otitis Externa (AOE)

Salvat1 site in 1 country493 target enrollmentJuly 22, 2017

ConditionsAcute Otitis Externa

InterventionsDF289 plus DF277 DF289 DF277

DrugsDF289 plus DF277 DF289 DF277

Overview

Phase: Phase 3
Intervention: DF289 plus DF277
Conditions: Acute Otitis Externa
Sponsor: Salvat
Enrollment: 493
Locations: 1
Primary Endpoint: Therapeutic Cure (Clinical + Microbiological Cure)
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine if a combination of an antibiotic plus a corticosteroid is safe and effective in treating AOE

Registry

clinicaltrials.gov

Start Date

July 22, 2017

End Date

September 14, 2018

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Salvat

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Uncomplicated AOE of less tan 21 days, defined as a total symptom score of at least 2 for otalgia, 2 for edema and 1 for otorrhea
•Brighton Grading of II or III
•Culture-based diagnosis of acute bacterial otitis externa
•Willingness to refrain from swimming through end of the study

Exclusion Criteria

•Previous episode of AOE within 4 weeks prior to enrollment, or 2 or more episodes of AOE within 6 months prior to the enrollment.
•Tympanic membrane perforation
•Any condition or situation likely to cause the patient to be unable or unwilling to comply with study treatment or attend all study visits
•Any condition in the patient or parent/guardian that, in the judgment of the principal investigator, could compromise patient safety, limit the patient's ability to complete the study, and/or compromise the objectives of the study

Arms & Interventions

DF289 plus DF277

Otic solution

Intervention: DF289 plus DF277

DF289

Otic solution

Intervention: DF289

DF277

Otic solution

Intervention: DF277

Outcomes

Primary Outcomes

Therapeutic Cure (Clinical + Microbiological Cure)

Time Frame: End of Treatment (Day 8+2)

Therapeutic cure will be considered achieved if edema, otalgia and otorrhea are resolved with no further requirement of antimicrobial therapy and bacteriological response is Eradication or Presumed Eradication