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

Phase 3

Completed

• Conditions: Acute Otitis Externa
• Interventions: Drug: DF289; Drug: DF277; Drug: DF289 plus DF277

• Registration Number: NCT03196973
• Lead Sponsor: Salvat

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-16
• Study First Submitted QC: 2017-06-20
• Study First Posted: 2017-06-23
• Study Start: 2017-07-22
• Primary Completion: 2018-08-31
• Study Completion: 2018-09-14
• Status Verified: 2020-11
• Results First Submitted: 2020-11-17
• Results First Submitted QC: 2021-03-16
• Last Update Submitted: 2021-03-16
• Results First Posted: 2021-04-09
• Last Update Posted: 2021-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 493

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DF289	DF289	Otic solution
DF277	DF277	Otic solution
DF289 plus DF277	DF289 plus DF277	Otic solution

Primary Outcome Measures

Name	Time	Method
Therapeutic Cure (Clinical + Microbiological Cure)	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 Outcome Measures

Name	Time	Method
Time to End of Pain	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

Trial Locations

Locations (1)

Laboratorios SALVAT; 🇪🇸 Esplugues de Llobregat, Spain