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

Par Pharmaceutical, Inc.23 sites in 1 country203 target enrollmentNovember 2013

ConditionsOtitis Media in Patients With Tympanostomy Tubes

InterventionsCIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%)Placebo Sterile Otic Suspension Ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension

DrugsCiprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%)Placebo Sterile Otic Suspension

Overview

Phase: Phase 3
Intervention: CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%)
Conditions: Otitis Media in Patients With Tympanostomy Tubes
Sponsor: Par Pharmaceutical, Inc.
Enrollment: 203
Locations: 23
Primary Endpoint: Clinical Success
Status: Terminated
Last Updated: 8 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) 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.

Registry

clinicaltrials.gov

Start Date

November 2013

End Date

March 2015

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Par Pharmaceutical, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female aged 6 months-12 years of age inclusive.
•Parent or legal guardian has signed informed consent form, which meets all of the criteria of current FDA regulations.
•Based on the patient's age, comprehension and communication developmental skills has provided assent to participate in an appropriate format.
•Confirmed insertion of a patent tympanostomy tube(s) in the infected ear(s).
•Clinical signs and symptoms consistent with acute bacterial otitis media in at least one ear and a score of at least 2 for otorrhea using the following scale 0=none, 1=mild, 2=moderate, 3=severe, (see Appendix A for rating scale and severity definitions).
•Otorrhea has been present for 21 days or less.
•The presence of infection confirmed by a positive bacterial culture for the presence of Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis or Pseudomonas aeruginosa. 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.

Exclusion Criteria

•Tympanostomy tube placement occurred within 3 days or less of screening visit.
•Tympanostomy tubes containing silver oxide or silver salts, or T-type tubes.
•Signs and symptoms of otitis media for longer than 21 days prior to being screened for inclusion in the study.
•Since the insertion of the tympanostomy tube(s), more than 1 previous episode of otitis media within the previous 3 months or more than 4 episodes within the previous 12 months.
•Provided any therapeutic drug treatment for current episode of otitis media within the previous 14 days.
•Current or previous history of any otologic surgery other than insertion/removal of tympanostomy tubes in infected ear(s).
•Clinical diagnosis that suggests current signs or symptoms are not caused by acute bacterial otitis media e.g. otitis externa
•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.

Arms & Interventions

Reference

CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%)

Intervention: CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%)

Placebo

Placebo Sterile Otic Suspension

Intervention: Placebo Sterile Otic Suspension

Test

Ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension

Intervention: Ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension

Outcomes

Primary Outcomes

Clinical Success

Time Frame: Day 14-21

A patient who is considered a "clinical success" at Visit 4 (Test of Cure/End of Study) will have no signs or symptoms of active AOMT that were present at baseline nor any new signs or symptoms of AOMT have developed