Clinical Study to Assess the 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: DF277; Drug: DF289; Drug: DF289 plus DF277

Study type: Interventional

Funder types: Industry

Identifiers

NCT01395966

DF289III/10IA02

Details and patient eligibility

About

The purpose of this study is to determine if the combination of DF289 plus DF277 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