E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with current or previous history of acute otitis media (AOM) and recurrent acute otitis media (RAOM). |
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E.1.1.1 | Medical condition in easily understood language |
Patients who suffer from acute ear inflammatory (Acute otitis media (AOM) and recurrent acute otitis media (RAOM). |
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E.1.1.2 | Therapeutic area | Diseases [C] - Ear, nose and throat diseases [C09] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10033079 |
E.1.2 | Term | Otitis media acute |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
Study is designed to determine pharmacokinetic, safety and tolerability bioequivalence of a topically applied product. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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).
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Safety and tolerability in pediatric patients. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | Yes |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | Yes |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | |