Bioequivalence of Two Ciprofloxacin 0.3%/Dexamethasone 0.1% Sterile Otic Suspensions in Otitis Media in Children With Tympanostomy Tubes
NCT ID: NCT01994642
Last Updated: 2017-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
203 participants
INTERVENTIONAL
2013-11-30
2015-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Reference
CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%)
CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%)
Placebo
Placebo Sterile Otic Suspension
Placebo Sterile Otic Suspension
Test
Ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension
Ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension
Interventions
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Ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension
CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%)
Placebo Sterile Otic Suspension
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
6 Months
12 Years
ALL
No
Sponsors
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Novum Pharmaceutical Research Services
INDUSTRY
Par Pharmaceutical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Chandra Vattikonda, Ph.D.
Role: STUDY_DIRECTOR
Par Pharamceutical, Inc.
Locations
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Birmingham Pediatrics
Birmingham, Alabama, United States
Agave Clinical Ressearch
Mesa, Arizona, United States
Arizona Center for Clinical Trials
Phoenix, Arizona, United States
Visions Clinical Research, Tuscon
Tucson, Arizona, United States
Alliance Research
Long Beach, California, United States
San Marcus Research Clinic
Miami, Florida, United States
Florida Medical Center and Research Inc.
Miami, Florida, United States
South Miami Clinical Research Group
Miami, Florida, United States
Miami Dade Medical Resarch Institute
Miami, Florida, United States
Global Health Research Center
Miami Lakes, Florida, United States
Winter Park Clinical Research
Winter Park, Florida, United States
Research Integrity
Owensboro, Kentucky, United States
Dr. Craig Spiegel
Bridgeton, Missouri, United States
Dr. Scott Mathei
Henderson, Nevada, United States
Piedmont Ear Nose and Throat Associates, PA
Winston-Salem, North Carolina, United States
Accecss MD, Clinical Resarch
Huber Heights, Ohio, United States
Cyn3gry
Gresham, Oregon, United States
Rainbow Research, Inc
Barnwell, South Carolina, United States
Dr. John Ansley
Orangeburg, South Carolina, United States
Spartanburg and Greer ENT
Spartanburg, South Carolina, United States
PMG Research of Bristol
Bristol, Tennessee, United States
Eagle Family Medical Associates
Crossville, Tennessee, United States
The Education and Research Foundation, Inc
Lynchburg, Virginia, United States
Countries
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Other Identifiers
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71205503
Identifier Type: -
Identifier Source: org_study_id