Clinical Trial: A Bioequivalence Study of Two Ciprofloxacin/Dexamethasone Formulations in Patients With Otitis Externa

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Multiple-Site Study to Evaluate the Clinical Equivalence of Ciprofloxacin 0.3%/Dexamethasone 0.1% Sterile Otic Suspension (Par) Compare

Brief 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 Pharmaceutical Companies, Inc.) to the already-marketed formulation CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%) sterile otic suspension (Alcon) in the treatment of acute bacterial otitis externa.

Detailed Summary:
Sponsor: Par Pharmaceutical, Inc.

Current Primary Outcome: Clinical Success [ Time Frame: Day 14-21 ]

Evaluation of the difference between the proportions of patients considered a clinical success at the End of Study visit


Original Primary Outcome: Same as current

Current Secondary Outcome: Resolution of Symptoms [ Time Frame: Day 14-21 ]

The time to complete resolution of disease specific clinically meaningful signs and symptoms at enrollment and the absence of new symptoms


Original Secondary Outcome: Same as current

Information By: Par Pharmaceutical, Inc.

Dates:
Date Received: July 25, 2013
Date Started: July 2013
Date Completion:
Last Updated: October 14, 2016
Last Verified: October 2016