E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute Otitis Media with Tympanostomy Tubes (AOMT) in Pediatric Patients |
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E.1.1.1 | Medical condition in easily understood language |
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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 | 14.1 |
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 |
The primary objective of the study is to evaluate the efficacy and safety of topical Ciprofloxacin 0.3% plus Fluocinolone Acetonide 0.025% otic solution twice a day for 7 days and the primary endpoint is to demonstrate therapeutic superiority for time to cessation of otorrhea over Ciprofloxacin 0.3% otic solution and over Fluocinolone Acetonide 0.025% otic solution, in patients suffering from AOMT. Otorrhea will be defined as ending on the first day on which the otorrhea is absent and remains absentuntil the end of the study. |
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E.2.2 | Secondary objectives of the trial |
The principal secondary endpoint is to demonstrate therapeutic superiority of Ciprofloxacin 0.3% plus Fluocinolone Acetonide 0.025% over Fluocinolone Acetonide 0.025% alone and Ciprofloxacin 0.3% over Fluocinolone Acetonide 0.025% alone with respect to sustained microbiological cure. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patient of either sex between 6 months and 12 years of age (both inclusive)
2. Patients with patent tympanostomy tube in the ear which will be treated (must be present and open)
3. Patients suffering from otorrhea for 3 weeks or less
4. Moderate or severe purulent otorrhea at inclusion
5. Signed informed consent from the patient?s legally authorized representative; also, if the patient is capable of providing assent, signed assent from the patient. |
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E.4 | Principal exclusion criteria |
1. Tympanostomy tube placement 3 days or less before study entry
2. Tympanostomy tubes containing antiseptic or antibacterial activity (silver oxide or silver salts), T-type tubes
3. Acute otitis externa or malignant otitis externa
4. Suspected viral, fungal, or mycobacterial ear infection
5. Otologic surgery within the previous year (other than tympanostomy tube placement)
6. Mastoiditis
7. Known or suspected quinolone and/or corticoids hypersensitivity
8. History of an immunosuppressive disorder, current immunosuppressive therapy, or diabetes
9. Acute or chronic renal disease, active hepatitis
10. Chronic nasal obstruction and/or persistent rhinorrhea
11. Craniofacial anomalies
12. Patient predisposed to neurosensory hearing loss
13. Use of topical nonsteroidal otic agents within one day of study entry
14. Use of topical or otic steroids within 3 days of enrollment or systemic steroids within 7 days of enrollment
15. Use of intranasal or inhaled steroids within 3 days of enrollment
16. Any infection requiring systemic antimicrobial therapy
17. Use of topical or systemic antimicrobial or antifungal agents within the previous 7 days of study entry or antimicrobial therapy for the current episode of AOMT.
18. Concurrent use of oral anti-inflammatory agents, except ibuprofen (analgesics without anti-inflammatory properties, such as acetaminophen are allowed)
19. Menarcheal female
20. Participation in another clinical trial in the previous 30 days |
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E.5 End points |
E.5.1 | Primary end point(s) |
To demonstrate superiority of Ciprofloxacin 0.3% plus Fluocinolone Acetonide 0.025% otic solution relative to Ciprofloxacin 0.3% otic solution and to Fluocinolone Acetonide 0.025% otic solution with respect to time to cessation of otorrhea.
Otorrhea will be defined as ending on the first day on which the otorrhea is absent and remains absent until the end of the study. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Otorrhea will be assessed at Visits 1, 2, 3, and 4 by the investigator |
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E.5.2 | Secondary end point(s) |
The principal secondary endpoint is to demonstrate therapeutic superiority of Ciprofloxacin 0.3% plus Fluocinolone Acetonide 0.025% otic solution over Fluocinolone Acetonide 0.025% otic solution and Ciprofloxacin 0.3% otic solution over Fluocinolone Acetonide 0.025% otic solution with respect to sustained microbiological cure. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The Microbiological cultures of middle ear will be taken at Visits 1, 3 and 4 (except when no exudate is present at Visit 3 or 4). |
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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 | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
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) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
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) | Yes |
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 | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 17 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Canada |
Czech Republic |
Denmark |
Finland |
Spain |
Sweden |
United States |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 22 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 22 |