Clinical trial NCT01910155: A Bioequivalence Study of Two Ciprofloxacin/Dexamethasone Formulations in Patients With Otitis Externa
Official title: A Randomized, Double-Blind, Placebo-Controlled, 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 Adults With Acute Bacterial Otitis Externa
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Otitis Externa
Lead sponsor: Par Pharmaceutical, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Novum Pharmaceutical Research Services
First posted: 2013-07-29
Enrollment: 455
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
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 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.


Eligibility criteria: Inclusion Criteria:

1. Male or non-pregnant, non lactating females 18-65 years of age inclusive.
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.
4. 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.
5. 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.

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

Primary outcomes:
measure: Clinical Success
timeFrame: Day 14-21
Secondary outcomes:
measure: Resolution of Symptoms
timeFrame: Day 14-21
Other outcomes:
Locations:
city: Tucson
country: United States
facility: James Donivan Gordon, MD
state: Arizona
city: Jonesboro
country: United States
facility: Nea Baptist Clinic
state: Arkansas
city: Little Rock
country: United States
facility: Applied Reserch Center
state: Arkansas
city: Carmichael
country: United States
facility: John Champlin, MD
state: California
city: Long Beach
country: United States
facility: Aliance Research
state: California
city: Boyton Beach
country: United States
facility: ENT of South Florida
state: Florida
city: Ft. Myers
country: United States
facility: Moore Clinical Research Inc
state: Florida
city: Hialeah
country: United States
facility: Jorge Diaz, MD
state: Florida
city: Miami
country: United States
facility: San Marcus Research Clinic
state: Florida
city: Miami
country: United States
facility: The Medical Consulting Center
state: Florida
city: Ormond Beach
country: United States
facility: Ormond Medical Arts Pharmaceutical Research Center
state: Florida
city: Winter Park
country: United States
facility: Winter Park Clinical Research
state: Florida
city: Owensboro
country: United States
facility: Research Integrity, LLC
state: Kentucky
city: Bellevue
country: United States
facility: Pioneer Clinical Research
state: Nebraska
city: Raleigh
country: United States
facility: PMG Research of Raleigh
state: North Carolina
city: Salisbury
country: United States
facility: PMG Research of Salisbury
state: North Carolina
city: Cincinnati
country: United States
facility: Julia Mullen, MD
state: Ohio
city: Ashland
country: United States
facility: Integrated Medical Research PC
state: Oregon
city: Gresham
country: United States
facility: Cyn3rgy
state: Oregon
city: Upper St. Clair
country: United States
facility: Peak Research LLC
state: Pennsylvania
city: Orangeburgh
country: United States
facility: John Ansley, MD
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg and Geer ENT
state: South Carolina
city: Brentwood
country: United States
facility: Monica Davis, MD
state: Tennessee
city: Arlington
country: United States
facility: Gilbert Ledesma, MD
state: Texas
city: Houston
country: United States
facility: West Houston Clinical Research Service
state: Texas
city: Lake Jackson
country: United States
facility: R-D Clinical Research
state: Texas
city: Lynchburg
country: United States
facility: The Education and Research Foundation Inc.
state: Virginia
city: Canovanas
country: Puerto Rico
facility: SMO The Clinical Research Group
city: Levittown
country: Puerto Rico
facility: Clinical Research Puerto Rico Guayama
city: Naranjito
country: Puerto Rico
facility: SMO The Clinical Research Group
city: San Juan
country: Puerto Rico
facility: SMO The Clinical Research Group
city: Santa Isabel
country: Puerto Rico
facility: SMO The Clinical Resarch Group
Study officials:
affiliation: Par Pharamceutical, Inc.
name: Chandra S Vattikonda, Ph.D.
role: STUDY_DIRECTOR
References: