A Bioequivalence Study of Two Ciprofloxacin/Dexamethasone Formulations in Patients With Otitis Externa
- Conditions
- Otitis Externa
- Interventions
- Registration Number
- NCT01910155
- Lead Sponsor
- Par Pharmaceutical, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 455
- 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.
- 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.
- Dermatitis of the infected ear such as psoriasis or seborrhea that would complicate evaluations.
- Significant underlying disease such as diabetes, HIV or other immunocompromised conditions or receiving therapy that may cause patient to be immunocompromised.
- 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.
- Investigator believes that severity of infection is such that systemic antibiotics would be the preferred treatment option.
- Use of any systemic antibacterial products or topical antibacterial products in the ear(s) within 28 days of screening for the study.
- 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.
- Use of any topical or otic medication in the affected ear within 2 weeks prior to screening.
- 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.
- Any known hypersensitivity to ciprofloxacin or other carboxyquinolone derivatives, dexamethasone or corticosteroids or other ingredients of the formulation.
- Receipt of any drug or device as part of a research study within 30 days prior to dosing.
- Previous participation in this study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Test Ciprofloxacin/Dexamethasone Ciprofloxacin/Dexamethasone Placebo Placebo Placebo Reference Ciprodex (R) Ciprodex (R)
- Primary Outcome Measures
Name Time Method Clinical Success Day 14-21 Evaluation of the difference between the proportions of patients considered a clinical success at the End of Study visit
- Secondary Outcome Measures
Name Time Method Resolution of Symptoms Day 14-21 The time to complete resolution of disease specific clinically meaningful signs and symptoms at enrollment and the absence of new symptoms
Trial Locations
- Locations (30)
Nea Baptist Clinic
🇺🇸Jonesboro, Arkansas, United States
John Champlin, MD
🇺🇸Carmichael, California, United States
Research Integrity, LLC
🇺🇸Owensboro, Kentucky, United States
Winter Park Clinical Research
🇺🇸Winter Park, Florida, United States
Monica Davis, MD
🇺🇸Brentwood, Tennessee, United States
Clinical Research Puerto Rico Guayama
🇵🇷Levittown, Puerto Rico
Aliance Research
🇺🇸Long Beach, California, United States
Integrated Medical Research PC
🇺🇸Ashland, Oregon, United States
ENT of South Florida
🇺🇸Boyton Beach, Florida, United States
PMG Research of Raleigh
🇺🇸Raleigh, North Carolina, United States
Pioneer Clinical Research
🇺🇸Bellevue, Nebraska, United States
The Education and Research Foundation Inc.
🇺🇸Lynchburg, Virginia, United States
SMO The Clinical Research Group
🇵🇷San Juan, Puerto Rico
Spartanburg and Geer ENT
🇺🇸Spartanburg, South Carolina, United States
SMO The Clinical Resarch Group
🇵🇷Santa Isabel, Puerto Rico
R-D Clinical Research
🇺🇸Lake Jackson, Texas, United States
San Marcus Research Clinic
🇺🇸Miami, Florida, United States
The Medical Consulting Center
🇺🇸Miami, Florida, United States
James Donivan Gordon, MD
🇺🇸Tucson, Arizona, United States
Applied Reserch Center
🇺🇸Little Rock, Arkansas, United States
Jorge Diaz, MD
🇺🇸Hialeah, Florida, United States
Moore Clinical Research Inc
🇺🇸Ft. Myers, Florida, United States
PMG Research of Salisbury
🇺🇸Salisbury, North Carolina, United States
John Ansley, MD
🇺🇸Orangeburgh, South Carolina, United States
Cyn3rgy
🇺🇸Gresham, Oregon, United States
Peak Research LLC
🇺🇸Upper St. Clair, Pennsylvania, United States
Gilbert Ledesma, MD
🇺🇸Arlington, Texas, United States
West Houston Clinical Research Service
🇺🇸Houston, Texas, United States
Ormond Medical Arts Pharmaceutical Research Center
🇺🇸Ormond Beach, Florida, United States
Julia Mullen, MD
🇺🇸Cincinnati, Ohio, United States