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

Acute Otitis Externa Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03196973
• Other study ID #: DF289OT3-16IA01
• Status: Completed
• Phase: Phase 3
• Start date: July 22, 2017
• Est. completion date: September 14, 2018

Study information

• Verified date: November 2020
• Source: Salvat
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 493
• Est. completion date: September 14, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Otitis Externa
• Otitis
• Otitis Externa

Intervention

Drug:
• DF289 plus DF277
1 vial into the affected ear twice daily for 7 days
• DF289
1 vial into the affected ear twice daily for 7 days
• DF277
1 vial into the affected ear twice daily for 7 days

Locations

Country	Name	City	State
Spain	Laboratorios SALVAT	Esplugues de Llobregat

Sponsors (1)

Lead Sponsor	Collaborator
Salvat

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Therapeutic Cure (Clinical + Microbiological Cure)	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	Time to End of Pain	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)