drugset / Trial / NCT01404611

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

NCT01404611

Phase 3 Completed 331 enrolled Salvat
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2011-06
Primary completion
2013-05
Completion
2013-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ciprofloxacin Small molecule 0.3 % Topical
Comparator fluocinolone acetonide Small molecule 0.025 % Topical

Indications