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Completed

NCT Number: NCT03196973

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

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

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Key information

Conditions

Acute Otitis Externa

Age range

6 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Laboratorios SALVAT

Esplugues de Llobregat, Spain

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

DF289 plus DF277

Drug

1 vial into the affected ear twice daily for 7 days

Other names: Antibiotic and Corticosteroid

DF289

Drug

1 vial into the affected ear twice daily for 7 days

Other names: Antibiotic

DF277

Drug

1 vial into the affected ear twice daily for 7 days

Other names: Corticosteroid

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Salvat

Industry

Registry information

Official study title

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)

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 23, 2017
Registry last updated
Apr 9, 2021

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.

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