Status:
COMPLETED
Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Middle Ear Infections in Pediatric Patients
Lead Sponsor:
Salvat
Conditions:
Acute Otitis Media
Eligibility:
All Genders
6-12 years
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- 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
- other ear diseases
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
331 Patients enrolled
Trial Details
Trial ID
NCT01404611
Start Date
June 1 2011
End Date
June 1 2013
Last Update
October 4 2017
Active Locations (1)
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1
Laboratorios SALVAT S.A.
Esplugues de Llobregat, Barcelona, Spain, 08950