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) Compared to CIPRODEX® (Ciprofloxacin 0.3%/Dexamethasone 0.1%) Sterile Otic Suspension (Alcon) in the Treatment of Adults With Acute Bacterial Otitis Externa

Par Pharmaceutical, Inc.30 sites in 2 countries455 target enrollmentJuly 2013

ConditionsOtitis Externa

InterventionsCiprofloxacin/Dexamethasone Ciprodex (R)Placebo

DrugsCiprofloxacin/Dexamethasone Ciprodex (R)Placebo

Overview

Phase: Phase 3
Intervention: Ciprofloxacin/Dexamethasone
Conditions: Otitis Externa
Sponsor: Par Pharmaceutical, Inc.
Enrollment: 455
Locations: 30
Primary Endpoint: Clinical Success
Status: Terminated
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2013

End Date

March 2015

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Par Pharmaceutical, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or non-pregnant, non lactating females 18-65 years of age inclusive.
•Signed informed consent form, which meets all of the criteria of current FDA regulations.
•If female and of child bearing potential, have a negative urine pregnancy test at the baseline visit and prepare to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g., condom, IUD, oral, injected, transdermal or implanted hormonal contraceptives). Patients on hormonal contraceptives must have been on the same method/type for at least 28 days prior to the start of the study and remain on the same throughout the study.
•The presence of infection confirmed by a positive bacterial culture for the presence of Pseudomonas aeruginosa or Staphylococcus aureus. As the results of the bacterial culture will not be immediately known, patients who meet all the other inclusion/exclusion criteria may be enrolled in the study pending the results of the bacterial culture.
•Clinical signs and symptoms consistent with bacterial otitis externa as defined by a combined Total Symptom Score (TSS) of at least 6 with a score of least 2 for otalgia using the following scale 0=none, 1=mild, 2=moderate, 3=severe.

Exclusion Criteria

•Females who are pregnant, breast feeding, or anticipate becoming pregnant during the study.
•Signs and symptoms of otitis externa for longer than 21 days prior to being screened for inclusion in the study.
•Previous episode of otitis externa within the previous 6 months or more than 2 episodes within the previous 12 months.
•Been provided any therapeutic drug treatment for current episode of otitis externa.
•Known history of, or ear exam reveals tympanic membrane perforation or damage for any reason.
•Current or previous history of any otologic surgery including insertion/removal of tympanostomy tubes in infected ear(s).
•Clinical diagnosis that suggests current signs or symptoms are not caused by acute bacterial otitis externa e.g. chronic suppurative otitis externa, acute otitis media
•Clinical diagnosis of malignant otitis externa
•Mastoid cavities, stenosis, exostosis or tumors of either ear or other noninfectious diseases of either ear.
•Suspected concurrent fungal or viral infection (e.g. herpes simplex) of either ear.