Patients with current or previous history of acute otitis media (AOM) and recurrent acute otitis media (RAOM). MedDRA version: 17.1 Level: PT Classification code 10033079 Term: Otitis media acute System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Ciprofloxacin (0.3%) and Dexamethasone (0.1%) otic suspension
Product Code: N/A
Pharmaceutical Form: Ear drops, suspension
INN or Proposed INN: Ciprofloxacin Hydrochloride
CAS Number: 8
Sponsors
Watson Laboratories Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Pediatric male or female patients aged between 5 to 12 years, inclusive, at the first time of signing of the informed consent by their parents/legal representatives. 2. Completed the screening process within 30 days prior to Baseline dosing. 3. Body mass index (BMI) between 5th and 95th percentile for age (see Appendix 2 and 3 for boys and girls, respectively). 4. Subject’s parents/legal representative has understood and signed the informed consent form for participation in the study, which meets all of the criteria of current FDA regulations. 5. Intact (confirmed by otholaryngological examination) tympanostomy tube(s), inserted no earlier than 3 months prior to randomization to the study due to acute otitis media. Criterion must be met during both, Screening and Baseline physical examination. 6. Judged by an investigator to be in good health as documented by the medical history, physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems), vital sign assessment, and clinical laboratory assessments. Any abnormalities or deviations outside the normal ranges for any of clinical testing (laboratory tests, vital signs) can be repeated at the discretion of the investigator(s) and judged to be not clinically significant for study participation. 7. Demonstrated negative screening test for hepatitis B surface antigen, hepatitis C antibody or HIV antibody (results available in subject’s medical file, performed within previous 3 months are also acceptable). 8. Negative urine pregnancy test in case of post-menarchal females (the day before or on the day of Baseline). Are the trial subjects under 18? yes Number of subjects for this age range: 28 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Reports receiving any investigational drug within 30 days prior to Baseline visit (dosing). 2. Reports of any presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, urologic, gastrointestinal, hepatic, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease as determined by the investigator(s). 3. Presence of any clinically significant results from laboratory tests, vital signs assessments, as judged by the investigator(s). 4. Signs and symptoms of acute otitis media within 30 days prior to being dosed in the study. 5. Perforated tympanic membrane in other place than tympanostomy tube placement. 6. Current or previous history of any otologic surgery other than insertion/removal of tympanostomy tubes in infected ear. 7. Clinical diagnosis of malignant otitis externa. 8. Mastoid cavities, stenosis, exostosis or tumors of either ear or other noninfectious diseases of either ear. 9. Suspected concurrent fungal or viral infection (e.g. herpes simplex) of either ear. 10. Dermatitis of the infected ear such as psoriasis or seborrhea that would complicate evaluations. 11. Any known hypersensitivity to ciprofloxacin or other carboxyquinolone derivatives, dexamethasone or corticosteroids or other ingredients of the formulation. 12. Receipt of any drug or device as part of a research study within 30 days prior to dosing. 13. Previous participation in this study. 14.Medications: a) Current or previous use of systemic steroids (within 30 days prior to screening and during screening period) or topical otic steroids (within 2 weeks prior to screening and during screening period). b) Current or previous otic treatment, topical antibiotics or any other otic product (i.e vinegar, alcohol, etc) within two (2) weeks prior to baseline. c) Current or previous use of systemic antibiotics within 3 (three) weeks prior to baseline. 15. Demonstrates a positive pregnancy test (if applicable). 16. Demonstrates a positive screening for hepatitis B surface antigen, hepatitis C antibody or HIV antibody. 17. Reports a clinically significant illness during the 30 days prior to Baseline dosing (as determined by the investigator(s)). 18. Reports a history of clinically significant allergies including food or drug allergies. 19. Reports donating blood (1 unit or 350 mL) or plasma (e.g. plasmapheresis) within 30 days prior to Baseline dosing. 20. Demonstrates, in the opinion of study staff, veins unsuitable for repeated venipuncture (e.g. veins difficult to locate, access, or puncture; veins with a tendency to rupture during or after puncture). 21. Use of any prescription drug therapy or over-the-counter (OTC) drugs 7 days prior to receiving study medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Study is designed to determine pharmacokinetic, safety and tolerability bioequivalence of a topically applied product. ;Primary end point(s): Assess the pharmacokinetics bioequivalence of Ciprofloxacin (0.3%) and Dexamethasone (0.1%) to the United States marketed Ciprodex® (ciprofloxacin 0.3% and dexamethasone 0.1%) Sterile Otic Suspension.;Timepoint(s) of evaluation of this end point: 1 day;Main Objective: To facilitate market entry this study will compare the pharmacokinetics of topically applied product - generic Ciprofloxacin (0.3%) and Dexamethasone (0.1%) to the United States marketed Ciprodex® (ciprofloxacin 0.3% and dexamethasone 0.1%) Sterile Otic Suspension in dose 4 drops in children (aged 5-12 years) with patent, intact tympanostomy tubes. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety and tolerability in pediatric patients.;Timepoint(s) of evaluation of this end point: 44+/-4 days | — |
Countries
Poland
Contacts
Public ContactClinical R&D Department
Watson Laboratories Inc.
Outcome results
None listed