NCT01994642

Bioequivalence of Two Ciprofloxacin 0.3%/Dexamethasone 0.1% Sterile Otic Suspensions in Otitis Media in Children With Tympanostomy Tubes

A Randomized, Double-Blind, Parallel Design, Multiple-Site Study to Evaluate the Clinical Equivalence of Ciprofloxacin 0.3%/Dexamethasone 0.1% Sterile Otic Suspension (Par) Compared to CIPRODEX® (Ciprofloxacin 0.3%/Dexamethasone 0.1%) Sterile Otic Suspension (Alcon) in the Treatment of Acute Bacterial Otitis Media in Children With Patent Tympanostomy Tubes

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 203 (actual)
• Sponsor: Par Pharmaceutical, Inc. · Industry
• Sex: All
• Age: 6 Months – 12 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to compare the relative efficacy and safety of the test formulation of ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension (Par) to the already-marketed formulation CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%) sterile otic suspension (Alcon) in the treatment of acute bacterial otitis media in children with patent tympanostomy tubes.

Conditions

• Otitis Media in Patients With Tympanostomy Tubes

Interventions

Type	Name	Description
DRUG	Ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension
DRUG	CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%)
DRUG	Placebo Sterile Otic Suspension

Timeline

• Start date: 2013-11-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2013-11-26
• Last updated: 2017-09-26

Locations

23 sites across 1 country: United States