A Bioequivalence Study of Two Ciprofloxacin/Dexamethasone Formulations in Patients With Otitis Externa

Otitis Externa Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01910155
• Other study ID #: 71205502
• Status: Terminated
• Phase: Phase 3
• First received: July 25, 2013
• Last updated: October 14, 2016
• Start date: July 2013
• Est. completion date: March 2015

Study information

• Verified date: October 2016
• Source: Par Pharmaceutical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 455
• Est. completion date: March 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Otitis
• Otitis Externa

Intervention

Drug:
• Ciprofloxacin/Dexamethasone

• Ciprodex (R)

• Placebo

Locations

Country	Name	City	State
Puerto Rico	SMO The Clinical Research Group	Canovanas
Puerto Rico	Clinical Research Puerto Rico Guayama	Levittown
Puerto Rico	SMO The Clinical Research Group	Naranjito
Puerto Rico	SMO The Clinical Research Group	San Juan
Puerto Rico	SMO The Clinical Resarch Group	Santa Isabel
United States	Gilbert Ledesma, MD	Arlington	Texas
United States	Integrated Medical Research PC	Ashland	Oregon
United States	Pioneer Clinical Research	Bellevue	Nebraska
United States	ENT of South Florida	Boyton Beach	Florida
United States	Monica Davis, MD	Brentwood	Tennessee
United States	John Champlin, MD	Carmichael	California
United States	Julia Mullen, MD	Cincinnati	Ohio
United States	Moore Clinical Research Inc	Ft. Myers	Florida
United States	Cyn3rgy	Gresham	Oregon
United States	Jorge Diaz, MD	Hialeah	Florida
United States	West Houston Clinical Research Service	Houston	Texas
United States	Nea Baptist Clinic	Jonesboro	Arkansas
United States	R-D Clinical Research	Lake Jackson	Texas
United States	Applied Reserch Center	Little Rock	Arkansas
United States	Aliance Research	Long Beach	California
United States	The Education and Research Foundation Inc.	Lynchburg	Virginia
United States	San Marcus Research Clinic	Miami	Florida
United States	The Medical Consulting Center	Miami	Florida
United States	John Ansley, MD	Orangeburgh	South Carolina
United States	Ormond Medical Arts Pharmaceutical Research Center	Ormond Beach	Florida
United States	Research Integrity, LLC	Owensboro	Kentucky
United States	PMG Research of Raleigh	Raleigh	North Carolina
United States	PMG Research of Salisbury	Salisbury	North Carolina
United States	Spartanburg and Geer ENT	Spartanburg	South Carolina
United States	James Donivan Gordon, MD	Tucson	Arizona
United States	Peak Research LLC	Upper St. Clair	Pennsylvania
United States	Winter Park Clinical Research	Winter Park	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Par Pharmaceutical, Inc.	Novum Pharmaceutical Research Services

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Success	Evaluation of the difference between the proportions of patients considered a clinical success at the End of Study visit	Day 14-21	No
Secondary	Resolution of Symptoms	The time to complete resolution of disease specific clinically meaningful signs and symptoms at enrollment and the absence of new symptoms	Day 14-21	No