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

NCT01910155 | Terminated Phase 3

• 1 other identifier: 71205502
• Study Type: interventional
• Target: 455
• Locations: 2 countries
• Sites: 32

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.

Conditions

Otitis Externa

Outcome Measures

Primary Outcomes (1)

• Clinical Success

  Evaluation of the difference between the proportions of patients considered a clinical success at the End of Study visit

  Day 14-21

Secondary Outcomes (1)

• Resolution of Symptoms

  Day 14-21

Study Arms (3)

Test

EXPERIMENTAL

Ciprofloxacin/Dexamethasone

Drug: Ciprofloxacin/Dexamethasone

Reference

ACTIVE COMPARATOR

Ciprodex (R)

Drug: Ciprodex (R)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Ciprofloxacin/Dexamethasone DRUG

Test

Ciprodex (R) DRUG

Reference

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Par Pharmaceutical, Inc.: lead
• Novum Pharmaceutical Research Services: collaborator

Study Sites (32)

James Donivan Gordon, MD

Tucson, Arizona, 85745, United States

Location

Nea Baptist Clinic

Jonesboro, Arkansas, 72401, United States

Location

Applied Reserch Center

Little Rock, Arkansas, 72212, United States

Location

John Champlin, MD

Carmichael, California, 95608, United States

Location

Aliance Research

Long Beach, California, 90813, United States

Location

ENT of South Florida

Boyton Beach, Florida, 33426, United States

Location

Moore Clinical Research Inc

Fort Myers, Florida, 33919, United States

Location

Jorge Diaz, MD

Hialeah, Florida, 33016, United States

Location

San Marcus Research Clinic

Miami, Florida, 33015, United States

Location

The Medical Consulting Center

Miami, Florida, 33125, United States

Location

Ormond Medical Arts Pharmaceutical Research Center

Ormond Beach, Florida, 32174, United States

Location

Winter Park Clinical Research

Winter Park, Florida, 32792, United States

Location

Research Integrity, LLC

Owensboro, Kentucky, 42303, United States

Location

Pioneer Clinical Research

Bellevue, Nebraska, 68005, United States

Location

PMG Research of Raleigh

Raleigh, North Carolina, 27609, United States

Location

PMG Research of Salisbury

Salisbury, North Carolina, 28144, United States

Location

Julia Mullen, MD

Cincinnati, Ohio, 45246, United States

Location

Integrated Medical Research PC

Ashland, Oregon, 97520, United States

Location

Cyn3rgy

Gresham, Oregon, 97030, United States

Location

Peak Research LLC

Upper Saint Clair, Pennsylvania, 15241, United States

Location

John Ansley, MD

Orangeburg, South Carolina, 29118, United States

Location

Spartanburg and Geer ENT

Spartanburg, South Carolina, 29303, United States

Location

Monica Davis, MD

Brentwood, Tennessee, 37027, United States

Location

Gilbert Ledesma, MD

Arlington, Texas, 76012, United States

Location

West Houston Clinical Research Service

Houston, Texas, 77055, United States

Location

R-D Clinical Research

Lake Jackson, Texas, 77566, United States

Location

The Education and Research Foundation Inc.

Lynchburg, Virginia, 24501, United States

Location

SMO The Clinical Research Group

Canovanas, PR, 00729, Puerto Rico

Location

Clinical Research Puerto Rico Guayama

Levittown, PR, 00949, Puerto Rico

Location

SMO The Clinical Research Group

Naranjito, PR, 00719, Puerto Rico

Location

SMO The Clinical Research Group

San Juan, PR, 00917, Puerto Rico

Location

SMO The Clinical Resarch Group

Santa Isabel, PR, 00757, Puerto Rico

Location

MeSH Terms

Conditions

Otitis Externa

Interventions

Ciprofloxacin; Dexamethasone

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Chandra S Vattikonda, Ph.D.

  Par Pharamceutical, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2013
• First Posted: July 29, 2013
• Study Start: July 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: March 1, 2015
• Last Updated: October 18, 2016

Record last verified: 2016-10

Locations

PR (5); US (27)