Phase 3
N=331
Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Middle Ear Infections in Pediatric Patients
Acute Otitis Media
Bottom Line
View on ClinicalTrials.gov: NCT01404611 ↗Enrolled (actual)
331
Serious AEs
0.6%
Results posted
Nov 2015
Primary outcome: Primary: Time to Cessation of Otorrhea — 6.83; 22; 4.94 days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- DF289 (Drug); DF277 (Drug); DF289 plus DF277 (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Salvat
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Cessation of Otorrhea |
6.83; 22; 4.94 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT01404611). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.