Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Middle Ear Infections in Pediatric Patients
Phase 3
Completed
- Conditions
- Acute Otitis Media
- Interventions
- Registration Number
- NCT01404611
- Lead Sponsor
- Salvat
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 331
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DF289 DF289 Ear drops DF277 DF277 Ear drops DF289 plus DF277 DF289 plus DF277 Ear drops
- Primary Outcome Measures
Name Time Method Time to Cessation of Otorrhea From baseline until the end of the study (up to 22 days)
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie DF289 and DF277 otic solution efficacy in acute otitis media with tympanostomy tubes?
How does DF289 plus DF277 combination therapy compare to standard-of-care antibiotics for pediatric AOMT treatment outcomes?
Are there specific biomarkers that predict response to corticosteroid-antibiotic combinations like DF289 plus DF277 in children with tympanostomy tubes?
What adverse event profiles have been observed with DF289, DF277, or their combination in phase 3 trials for middle ear infections?
What are the current clinical and research developments in otic solutions for acute otitis media with tympanostomy tubes by Salvat and competitors?
Trial Locations
- Locations (1)
Laboratorios SALVAT S.A.
🇪🇸Esplugues de Llobregat, Barcelona, Spain
Laboratorios SALVAT S.A.🇪🇸Esplugues de Llobregat, Barcelona, Spain