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

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Salvat

Criteria

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