Bioequivalence of Two Ciprofloxacin 0.3%/Dexamethasone 0.1% Sterile Otic Suspensions in Otitis Media in Children With Tympanostomy Tubes

NCT01994642 | Terminated Phase 3

• 1 other identifier: 71205503
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 23

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) to the already-marketed formulation CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%) sterile otic suspension (Alcon) in the treatment of acute bacterial otitis media in children with patent tympanostomy tubes.

Conditions

Otitis Media in Patients With Tympanostomy Tubes

Outcome Measures

Primary Outcomes (1)

• Clinical Success

  A patient who is considered a "clinical success" at Visit 4 (Test of Cure/End of Study) will have no signs or symptoms of active AOMT that were present at baseline nor any new signs or symptoms of AOMT have developed

  Day 14-21

Secondary Outcomes (1)

• Cessation of Otorrhea

  Day 14-21

Study Arms (3)

Reference

ACTIVE COMPARATOR

CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%)

Drug: CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%)

Placebo

PLACEBO COMPARATOR

Placebo Sterile Otic Suspension

Drug: Placebo Sterile Otic Suspension

Test

EXPERIMENTAL

Ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension

Drug: Ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension

Interventions

Ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension DRUG

Test

CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%) DRUG

Reference

Placebo Sterile Otic Suspension DRUG

Placebo

Eligibility Criteria

• Age: 6 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or female aged 6 months-12 years of age inclusive.
• Parent or legal guardian has signed informed consent form, which meets all of the criteria of current FDA regulations.
• Based on the patient's age, comprehension and communication developmental skills has provided assent to participate in an appropriate format.
• Confirmed insertion of a patent tympanostomy tube(s) in the infected ear(s).
• Clinical signs and symptoms consistent with acute bacterial otitis media in at least one ear and a score of at least 2 for otorrhea using the following scale 0=none, 1=mild, 2=moderate, 3=severe, (see Appendix A for rating scale and severity definitions).
• Otorrhea has been present for 21 days or less.

You may not qualify if:

• Tympanostomy tube placement occurred within 3 days or less of screening visit.
• Tympanostomy tubes containing silver oxide or silver salts, or T-type tubes.
• Since the insertion of the tympanostomy tube(s), more than 1 previous episode of otitis media within the previous 3 months or more than 4 episodes within the previous 12 months.
• Provided any therapeutic drug treatment for current episode of otitis media within the previous 14 days.
• Current or previous history of any otologic surgery other than insertion/removal of tympanostomy tubes in infected ear(s).
• Clinical diagnosis that suggests current signs or symptoms are not caused by acute bacterial otitis media e.g. otitis externa
• 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.
• Any known hypersensitivity to ciprofloxacin or other carboxyquinolone derivatives, dexamethasone or corticosteroids or other ingredients of the formulation.
• 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 14 days of screening for the study.

Sponsors & Collaborators

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

Study Sites (23)

Birmingham Pediatrics

Birmingham, Alabama, 32505, United States

Location

Agave Clinical Ressearch

Mesa, Arizona, 85202, United States

Location

Arizona Center for Clinical Trials

Phoenix, Arizona, 85003, United States

Location

Visions Clinical Research, Tuscon

Tucson, Arizona, 85712, United States

Location

Alliance Research

Long Beach, California, 90813, United States

Location

San Marcus Research Clinic

Miami, Florida, 33015, United States

Location

Florida Medical Center and Research Inc.

Miami, Florida, 33142, United States

Location

South Miami Clinical Research Group

Miami, Florida, 33142, United States

Location

Miami Dade Medical Resarch Institute

Miami, Florida, 33176, United States

Location

Global Health Research Center

Miami Lakes, Florida, 33016, United States

Location

Winter Park Clinical Research

Winter Park, Florida, 32792, United States

Location

Research Integrity

Owensboro, Kentucky, 42303, United States

Location

Dr. Craig Spiegel

Bridgeton, Missouri, 63044, United States

Location

Dr. Scott Mathei

Henderson, Nevada, 89704, United States

Location

Piedmont Ear Nose and Throat Associates, PA

Winston-Salem, North Carolina, 27103, United States

Location

Accecss MD, Clinical Resarch

Huber Heights, Ohio, 45424, United States

Location

Cyn3gry

Gresham, Oregon, 97030, United States

Location

Rainbow Research, Inc

Barnwell, South Carolina, 29812, United States

Location

Dr. John Ansley

Orangeburg, South Carolina, 29118, United States

Location

Spartanburg and Greer ENT

Spartanburg, South Carolina, 29303, United States

Location

PMG Research of Bristol

Bristol, Tennessee, 37620, United States

Location

Eagle Family Medical Associates

Crossville, Tennessee, 38555, United States

Location

The Education and Research Foundation, Inc

Lynchburg, Virginia, 24501, United States

Location

MeSH Terms

Interventions

Ciprofloxacin; Dexamethasone

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 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: November 20, 2013
• First Posted: November 26, 2013
• Study Start: November 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: September 26, 2017

Record last verified: 2017-09

Locations

US (23)