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

Salvat

Status and phase: Completed; Phase 3

Conditions: Acute Otitis Media

Treatments: Drug: DF289 plus DF277; Drug: DF289; Drug: DF277

Study type: Interventional

Funder types: Industry

Identifiers

NCT01404611

DF289III/10IA04

Details and patient eligibility

About

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.

Enrollment: 331 patients

Sex: All

Ages: 6 months to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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331 participants in 3 patient groups

DF289

Active Comparator group

Description:

Ear drops

Treatment:

Drug: DF289

DF277

Active Comparator group

Description:

Ear drops

Treatment:

Drug: DF277

DF289 plus DF277

Experimental group

Description:

Ear drops

Treatment:

Drug: DF289 plus DF277