Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Acute Otitis Externa

March 16, 2021 updated by: Salvat

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

493

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Esplugues de Llobregat, Spain
        • Laboratorios SALVAT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DF289 plus DF277
Otic solution
Drug: DF289 plus DF277
1 vial into the affected ear twice daily for 7 days
Other Names:
  • Antibiotic and Corticosteroid
Active Comparator: DF289
Otic solution
Drug: DF289
1 vial into the affected ear twice daily for 7 days
Other Names:
  • Antibiotic
Active Comparator: DF277
Otic solution
Drug: DF277
1 vial into the affected ear twice daily for 7 days
Other Names:
  • Corticosteroid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
End of Treatment (Day 8+2)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to End of Pain
Time Frame: From baseline to End of Study (Day 15+2)
First day on which there is no use of analgesics, the pain score is zero and remains zero until end of study
From baseline to End of Study (Day 15+2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Salvat

Investigators

  • Study Director: Enrique Jiménez, Salvat

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2017

Primary Completion (Actual)

August 31, 2018

Study Completion (Actual)

September 14, 2018

Study Registration Dates

First Submitted

June 16, 2017

First Submitted That Met QC Criteria

June 20, 2017

First Posted (Actual)

June 23, 2017

Study Record Updates

Last Update Posted (Actual)

April 9, 2021

Last Update Submitted That Met QC Criteria

March 16, 2021

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DF289OT3-16IA01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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