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

NCT03196973 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 493

Last updated 2021-04-09

Study results available
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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

Conditions

  • Acute Otitis Externa

Interventions

DRUG

DF289 plus DF277

1 vial into the affected ear twice daily for 7 days

DRUG

DF289

1 vial into the affected ear twice daily for 7 days

DRUG

DF277

1 vial into the affected ear twice daily for 7 days

Sponsors & Collaborators

  • Salvat

    lead INDUSTRY

Principal Investigators

  • Enrique Jiménez · Salvat

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-22
Primary Completion
2018-08-31
Completion
2018-09-14
FDA Drug
Yes

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03196973 on ClinicalTrials.gov