Clinical Study to Assess the 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
- NCT01395966
- Lead Sponsor
- Salvat
- Brief Summary
The purpose of this study is to determine if the combination of DF289 plus DF277 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's efficacy in treating acute otitis media in pediatric patients with tympanostomy tubes?
How does the DF289 plus DF277 combination compare to standard-of-care antibiotics like amoxicillin-clavulanate in treating middle ear infections in children with ear tubes?
Are there specific biomarkers that can predict response to DF289 plus DF277 otic solution in acute otitis media patients with tympanostomy tubes?
What are the known or potential adverse events associated with DF289 plus DF277 otic solution in pediatric populations, and how are they managed?
What other otic solutions or combination therapies are being developed by Salvat for middle ear infections, and how do they compare to DF289 plus DF277 in terms of efficacy and safety?
Trial Locations
- Locations (1)
Laboratorios Salvat, S.A.
🇪🇸Esplugues de Llobregat, Barcelona, Spain