NCT01404611
Completed
Phase 3
A Multicenter, Randomized, Double-Blind Clinical Trial to Assess the Efficacy and Safety of DF289 Plus DF277 Otic Solution Compared to DF289 Otic Solution and to DF277 Otic Solution in the Treatment of Acute Otitis Media With Tympanostomy Tubes (AOMT) in Pediatric Patients
Salvat1 site in 1 country331 target enrollmentJune 2011
Overview
- Phase
- Phase 3
- Intervention
- DF289
- Conditions
- Acute Otitis Media
- Sponsor
- Salvat
- Enrollment
- 331
- Locations
- 1
- Primary Endpoint
- Time to Cessation of Otorrhea
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility 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
Arms & Interventions
DF289
Ear drops
Intervention: DF289
DF277
Ear drops
Intervention: DF277
DF289 plus DF277
Ear drops
Intervention: DF289 plus DF277
Outcomes
Primary Outcomes
Time to Cessation of Otorrhea
Time Frame: From baseline until the end of the study (up to 22 days)
Study Sites (1)
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