A Bioequivalence Study of Two Ciprofloxacin/Dexamethasone Formulations in Patients With Otitis Externa
NCT ID: NCT01910155
Last Updated: 2016-10-18
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
455 participants
INTERVENTIONAL
2013-07-31
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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Test
Ciprofloxacin/Dexamethasone
Ciprofloxacin/Dexamethasone
Reference
Ciprodex (R)
Ciprodex (R)
Placebo
Placebo
Placebo
Interventions
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Ciprofloxacin/Dexamethasone
Ciprodex (R)
Placebo
Eligibility Criteria
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Inclusion Criteria
2. Signed informed consent form, which meets all of the criteria of current FDA regulations.
3. 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.
Exclusion Criteria
1. Females who are pregnant, breast feeding, or anticipate becoming pregnant during the study.
2. Signs and symptoms of otitis externa for longer than 21 days prior to being screened for inclusion in the study.
3. Previous episode of otitis externa within the previous 6 months or more than 2 episodes within the previous 12 months.
4. Been provided any therapeutic drug treatment for current episode of otitis externa.
5. Known history of, or ear exam reveals tympanic membrane perforation or damage for any reason.
6. Current or previous history of any otologic surgery including 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 externa e.g. chronic suppurative otitis externa, acute otitis media
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. Significant underlying disease such as diabetes, HIV or other immunocompromised conditions or receiving therapy that may cause patient to be immunocompromised.
13. 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.
14. Investigator believes that severity of infection is such that systemic antibiotics would be the preferred treatment option.
15. Use of any systemic antibacterial products or topical antibacterial products in the ear(s) within 28 days of screening for the study.
16. 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.
17. Use of any topical or otic medication in the affected ear within 2 weeks prior to screening.
18. 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.
19. Any known hypersensitivity to ciprofloxacin or other carboxyquinolone derivatives, dexamethasone or corticosteroids or other ingredients of the formulation.
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
18 Years
65 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 S Vattikonda, Ph.D.
Role: STUDY_DIRECTOR
Par Pharamceutical, Inc.
Locations
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James Donivan Gordon, MD
Tucson, Arizona, United States
Nea Baptist Clinic
Jonesboro, Arkansas, United States
Applied Reserch Center
Little Rock, Arkansas, United States
John Champlin, MD
Carmichael, California, United States
Aliance Research
Long Beach, California, United States
ENT of South Florida
Boyton Beach, Florida, United States
Moore Clinical Research Inc
Fort Myers, Florida, United States
Jorge Diaz, MD
Hialeah, Florida, United States
San Marcus Research Clinic
Miami, Florida, United States
The Medical Consulting Center
Miami, Florida, United States
Ormond Medical Arts Pharmaceutical Research Center
Ormond Beach, Florida, United States
Winter Park Clinical Research
Winter Park, Florida, United States
Research Integrity, LLC
Owensboro, Kentucky, United States
Pioneer Clinical Research
Bellevue, Nebraska, United States
PMG Research of Raleigh
Raleigh, North Carolina, United States
PMG Research of Salisbury
Salisbury, North Carolina, United States
Julia Mullen, MD
Cincinnati, Ohio, United States
Integrated Medical Research PC
Ashland, Oregon, United States
Cyn3rgy
Gresham, Oregon, United States
Peak Research LLC
Upper Saint Clair, Pennsylvania, United States
John Ansley, MD
Orangeburg, South Carolina, United States
Spartanburg and Geer ENT
Spartanburg, South Carolina, United States
Monica Davis, MD
Brentwood, Tennessee, United States
Gilbert Ledesma, MD
Arlington, Texas, United States
West Houston Clinical Research Service
Houston, Texas, United States
R-D Clinical Research
Lake Jackson, Texas, United States
The Education and Research Foundation Inc.
Lynchburg, Virginia, United States
SMO The Clinical Research Group
Canovanas, PR, Puerto Rico
Clinical Research Puerto Rico Guayama
Levittown, PR, Puerto Rico
SMO The Clinical Research Group
Naranjito, PR, Puerto Rico
SMO The Clinical Research Group
San Juan, PR, Puerto Rico
SMO The Clinical Resarch Group
Santa Isabel, PR, Puerto Rico
Countries
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Other Identifiers
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71205502
Identifier Type: -
Identifier Source: org_study_id
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