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 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: 27 Oct 2014

At a glance

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

    • 11 Oct 2014 Status changed from recruiting to completed as reported by European Clinical Trials Database record.
    • 23 Jun 2012 Additional trial locations added as reported by European Clinical Trials Database.
    • 28 Dec 2011 New trial record
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