Trials / Completed
CompletedNCT01404611
Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Middle Ear Infections in Pediatric Patients
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 331 (actual)
- Sponsor
- Salvat · Industry
- Sex
- All
- Age
- 6 Months – 12 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | DF289 | Ear drops |
| DRUG | DF277 | Ear drops |
| DRUG | DF289 plus DF277 | Ear drops |
Timeline
- Start date
- 2011-06-01
- Primary completion
- 2013-05-01
- Completion
- 2013-06-01
- First posted
- 2011-07-28
- Last updated
- 2017-10-04
- Results posted
- 2015-11-23
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT01404611. Inclusion in this directory is not an endorsement.