Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Middle Ear Infections in Pediatric Patients

Salvat331 enrolled

Overview

The purpose of this study is to determine if a combination of an antibiotic plus a corticosteroid is safe and effective in treating middle ear infections in children with ear tubes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

331

Conditions

Acute Otitis Media

Interventions

DF289DRUG

Ear drops

DF277DRUG

Ear drops

DF289 plus DF277DRUG

Ear drops

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 6 months to 12 years * ear tube in the ear which will be treated * otorrhea for 3 weeks or less * moderate or severe otorrhea Exclusion Criteria: * other ear diseases

Locations (1)

Laboratorios SALVAT S.A.

Esplugues de Llobregat, Barcelona, Spain

Outcomes

Primary Outcomes

Time to Cessation of Otorrhea

Time frame: From baseline until the end of the study (up to 22 days)

Data from ClinicalTrials.gov

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