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

This study has been terminated.
(FDA's draft guidance (revised March 2015) provided two options for determining bioequivalence: 1) in-vitro or 2) in-vivo studies)
Novum Pharmaceutical Research Services
Information provided by (Responsible Party):
Par Pharmaceutical, Inc. Identifier:
First received: November 20, 2013
Last updated: June 1, 2015
Last verified: June 2015
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.

Condition Intervention Phase
Otitis Media in Patients With Tympanostomy Tubes.
Drug: Ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension
Drug: CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%)
Drug: Placebo Sterile Otic Suspension
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, 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 Acute Bacterial Otitis Media in Children With Patent Tympanostomy Tubes

Resource links provided by NLM:

Further study details as provided by Par Pharmaceutical, Inc.:

Primary Outcome Measures:
  • Clinical Success [ Time Frame: Day 14-21 ] [ Designated as safety issue: No ]
    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

Secondary Outcome Measures:
  • Cessation of Otorrhea [ Time Frame: Day 14-21 ] [ Designated as safety issue: No ]

Enrollment: 203
Study Start Date: November 2013
Estimated Study Completion Date: March 2016
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Reference
CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%)
Drug: CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%)
Placebo Comparator: Placebo
Placebo Sterile Otic Suspension
Drug: Placebo Sterile Otic Suspension
Experimental: Test
Ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension
Drug: Ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension


Ages Eligible for Study:   6 Months to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male or female aged 6 months-12 years of age inclusive.
  2. Parent or legal guardian has signed informed consent form, which meets all of the criteria of current FDA regulations.
  3. Based on the patient's age, comprehension and communication developmental skills has provided assent to participate in an appropriate format.
  4. Confirmed insertion of a patent tympanostomy tube(s) in the infected ear(s).
  5. 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).
  6. Otorrhea has been present for 21 days or less.
  7. The presence of infection confirmed by a positive bacterial culture for the presence of Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis or Pseudomonas aeruginosa. 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.

Exclusion Criteria:

  1. Tympanostomy tube placement occurred within 3 days or less of screening visit.
  2. Tympanostomy tubes containing silver oxide or silver salts, or T-type tubes.
  3. Signs and symptoms of otitis media for longer than 21 days prior to being screened for inclusion in the study.
  4. 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.
  5. Provided any therapeutic drug treatment for current episode of otitis media within the previous 14 days.
  6. Current or previous history of any otologic surgery other than 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 media e.g. otitis externa
  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. Any known hypersensitivity to ciprofloxacin or other carboxyquinolone derivatives, dexamethasone or corticosteroids or other ingredients of the formulation.
  13. Significant underlying disease such as diabetes, HIV or other immunocompromised conditions or receiving therapy that may cause patient to be immunocompromised.
  14. 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.
  15. Investigator believes that severity of infection is such that systemic antibiotics would be the preferred treatment option.
  16. Use of any systemic antibacterial products or topical antibacterial products in the ear(s) within 14 days of screening for the study.
  17. 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.
  18. Use of any topical or otic medication in the affected ear within 7 days prior to screening.
  19. 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.
  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01994642

United States, Alabama
Birmingham Pediatrics
Birmingham, Alabama, United States, 32505
United States, Arizona
Agave Clinical Ressearch
Mesa, Arizona, United States, 85202
Arizona Center for Clinical Trials
Phoenix, Arizona, United States, 85003
Visions Clinical Research, Tuscon
Tuscon, Arizona, United States, 85712
United States, California
Alliance Research
Long Beach, California, United States, 90813
United States, Florida
Florida Medical Center and Research Inc.
Miami, Florida, United States, 33142
Miami Dade Medical Resarch Institute
Miami, Florida, United States, 33176
San Marcus Research Clinic
Miami, Florida, United States, 33015
South Miami Clinical Research Group
Miami, Florida, United States, 33142
Global Health Research Center
Miami Lakes, Florida, United States, 33016
Winter Park Clinical Research
Winter Park, Florida, United States, 32792
United States, Kentucky
Research Integrity
Owensboro, Kentucky, United States, 42303
United States, Missouri
Dr. Craig Spiegel
Bridgeton, Missouri, United States, 63044
United States, Nevada
Dr. Scott Mathei
Henderson, Nevada, United States, 89704
United States, North Carolina
Piedmont Ear Nose and Throat Associates, PA
Winston Salem, North Carolina, United States, 27103
United States, Ohio
Accecss MD, Clinical Resarch
Huber Heights, Ohio, United States, 45424
United States, Oregon
Gresham, Oregon, United States, 97030
United States, South Carolina
Rainbow Research, Inc
Barnwell, South Carolina, United States, 29812
Dr. John Ansley
Orangeburgh, South Carolina, United States, 29118
Spartanburg and Greer ENT
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
PMG Research of Bristol
Bristol, Tennessee, United States, 37620
Eagle Family Medical Associates
Crossville, Tennessee, United States, 38555
United States, Virginia
The Education and Research Foundation, Inc
Lynchburg, Virginia, United States, 24501
Sponsors and Collaborators
Par Pharmaceutical, Inc.
Novum Pharmaceutical Research Services
Study Director: Chandra Vattikonda, Ph.D. Par Pharamceutical, Inc.
  More Information

No publications provided

Responsible Party: Par Pharmaceutical, Inc. Identifier: NCT01994642     History of Changes
Other Study ID Numbers: 71205503
Study First Received: November 20, 2013
Last Updated: June 1, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases
BB 1101
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors processed this record on November 27, 2015