Clinical trial NCT01994642: Bioequivalence of Two Ciprofloxacin 0.3%/Dexamethasone 0.1% Sterile Otic Suspensions in Otitis Media in Children With Tympanostomy Tubes
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Otitis Media in Patients With Tympanostomy Tubes
Lead sponsor: Par Pharmaceutical, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Novum Pharmaceutical Research Services
First posted: 2013-11-26
Enrollment: 203
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Male or female aged 6 months-12 years of age inclusive.
2. Parent or legal guardian has signed informed consent form, which meets all of the criteria of current FDA regulations.
3. Based on the patient's age, comprehension and communication developmental skills has provided assent to participate in an appropriate format.
4. Confirmed insertion of a patent tympanostomy tube(s) in the infected ear(s).
5. 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).
6. Otorrhea has been present for 21 days or less.
7. 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:

1. Tympanostomy tube placement occurred within 3 days or less of screening visit.
2. Tympanostomy tubes containing silver oxide or silver salts, or T-type tubes.
3. Signs and symptoms of otitis media for longer than 21 days prior to being screened for inclusion in the study.
4. 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.
5. Provided any therapeutic drug treatment for current episode of otitis media within the previous 14 days.
6. Current or previous history of any otologic surgery other than insertion/removal of tympanostomy tubes in infected ear(s).
7. Clinical diagnosis that suggests current signs or symptoms are not caused by acute bacterial otitis media e.g. otitis externa
8. Clinical diagnosis of malignant otitis externa
9. Mastoid cavities, stenosis, exostosis or tumors of either ear or other noninfectious diseases of either ear.
10. Suspected concurrent fungal or viral infection (e.g. herpes simplex) of either ear.
11. Dermatitis of the infected ear such as psoriasis or seborrhea that would complicate evaluations.
12. Any known hypersensitivity to ciprofloxacin or other carboxyquinolone derivatives, dexamethasone or corticosteroids or other ingredients of the formulation.
13. Significant underlying disease such as diabetes, HIV or other immunocompromised conditions or receiving therapy that may cause patient to be immunocompromised.
14. Significant history or current evidence of chronic infectious disease, system disorder, organ disorder or other medical condition that in the Investigator's opinion would place the study patient at undue risk by participation or could jeopardize the integrity of the study evaluations.
15. Investigator believes that severity of infection is such that systemic antibiotics would be the preferred treatment option.
16. Use of any systemic antibacterial products or topical antibacterial products in the ear(s) within 14 days of screening for the study.
17. Use of any systemic anti-inflammatory products or topical anti-inflammatory products in the ear(s) (such as corticosteroids and NSAIDs) within 7 days of screening for the study.
18. Use of any topical or otic medication in the affected ear within 7 days prior to screening.
19. Use of any astringents such as vinegar, alcohol or medicated cleansing or swabbing of the ear within 48 hours of the baseline bacterial culture swab.
20. Receipt of any drug or device as part of a research study within 30 days prior to dosing.
21. Previous participation in this study.

Primary outcomes:
measure: Clinical Success
timeFrame: Day 14-21
Secondary outcomes:
measure: Cessation of Otorrhea
timeFrame: Day 14-21
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Pediatrics
state: Alabama
city: Mesa
country: United States
facility: Agave Clinical Ressearch
state: Arizona
city: Phoenix
country: United States
facility: Arizona Center for Clinical Trials
state: Arizona
city: Tucson
country: United States
facility: Visions Clinical Research, Tuscon
state: Arizona
city: Long Beach
country: United States
facility: Alliance Research
state: California
city: Miami Lakes
country: United States
facility: Global Health Research Center
state: Florida
city: Miami
country: United States
facility: San Marcus Research Clinic
state: Florida
city: Miami
country: United States
facility: Florida Medical Center and Research Inc.
state: Florida
city: Miami
country: United States
facility: South Miami Clinical Research Group
state: Florida
city: Miami
country: United States
facility: Miami Dade Medical Resarch Institute
state: Florida
city: Winter Park
country: United States
facility: Winter Park Clinical Research
state: Florida
city: Owensboro
country: United States
facility: Research Integrity
state: Kentucky
city: Bridgeton
country: United States
facility: Dr. Craig Spiegel
state: Missouri
city: Henderson
country: United States
facility: Dr. Scott Mathei
state: Nevada
city: Winston-Salem
country: United States
facility: Piedmont Ear Nose and Throat Associates, PA
state: North Carolina
city: Huber Heights
country: United States
facility: Accecss MD, Clinical Resarch
state: Ohio
city: Gresham
country: United States
facility: Cyn3gry
state: Oregon
city: Barnwell
country: United States
facility: Rainbow Research, Inc
state: South Carolina
city: Orangeburg
country: United States
facility: Dr. John Ansley
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg and Greer ENT
state: South Carolina
city: Bristol
country: United States
facility: PMG Research of Bristol
state: Tennessee
city: Crossville
country: United States
facility: Eagle Family Medical Associates
state: Tennessee
city: Lynchburg
country: United States
facility: The Education and Research Foundation, Inc
state: Virginia
Study officials:
affiliation: Par Pharamceutical, Inc.
name: Chandra Vattikonda, Ph.D.
role: STUDY_DIRECTOR
References: