Phase 3
N=331
Clinical Study to Assess the 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: NCT01395966 ↗Enrolled (actual)
331
Serious AEs
0.0%
Results posted
Oct 2015
Primary outcome: Primary: Time to Cessation of Otorrhea — 7.69; 22; 3.75 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
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Cessation of Otorrhea |
7.69; 22; 3.75 | — |
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.
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 (NCT01395966). 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.