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 [A Multicenter, Randomized, Double-Blind Clinical Trial to Assess the Efficacy and Safety of Ciprofloxacin 0.3% Plus Fluocinolone Acetonide 0.025% Otic Solution Compared to Ciprofloxacin 0.3% Otic Solution and to Fluocinolone Acetonide 0.025% Otic Solution in the Treatment of Acute Otitis Media With Tympanostomy Tubes (AOMT) in Pediatric Patients]

Trial Profile

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 [A Multicenter, Randomized, Double-Blind Clinical Trial to Assess the Efficacy and Safety of Ciprofloxacin 0.3% Plus Fluocinolone Acetonide 0.025% Otic Solution Compared to Ciprofloxacin 0.3% Otic Solution and to Fluocinolone Acetonide 0.025% Otic Solution in the Treatment of Acute Otitis Media With Tympanostomy Tubes (AOMT) in Pediatric Patients]

Completed
Phase of Trial: Phase III

Latest Information Update: 30 Sep 2017

At a glance

  • Drugs Ciprofloxacin/fluocinolone acetonide (Primary) ; Ciprofloxacin; Fluocinolone acetonide
  • Indications Otitis media
  • Focus Registrational; Therapeutic Use
  • Sponsors SALVAT
  • Most Recent Events

    • 01 Jun 2013 Status changed from recruiting to completed as reported by ClinicalTrials.gov.
    • 28 May 2013 Enrollment is expected to be completed in November 2013, according to a SALVAT media release.
    • 04 Aug 2012 Additional locations added as reported by European Clinical Trials Database.
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