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 |
Otitis Media Aguda con Tubos de Timpanostomía(AOMT) en Pacientes Pediatricos |
|
E.1.1.1 | Medical condition in easily understood language |
ear infection |
infección de oido |
|
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 | 14.0 |
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 |
|
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. |
El objetivo principal del estudio es evaluar la eficacia y la seguridad de ciprofloxacino 0,3% más Fluocinolona acetónido 0,025% solución ótica tópica dos veces al día durante 7 días, y el criterio principal de valoración es demostrar la superioridad terapéutica mediante el tiempo hasta el cese de la otorrea respecto a ciprofloxacino 0,3% solución ótica y respecto a fluocinolona acetónido 0,025% solución ótica en pacientes que presentan una OMAT. La otorrea se definirá como terminada el primer día en que esté ausente y se mantenga ausente hasta el final del estudio. |
|
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. |
El principal criterio secundario de valoración es demostrar la superioridad terapéutica de ciprofloxacino 0,3% más fluocinolona acetónido 0,025% frente a fluocinolona acetónido 0,025% sola, y ciprofloxacino 0,3% solo frente a fluocinolona acetónido 0,025% sola con respecto a la curación microbiológica mantenida. |
|
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. |
1.Pacientes de ambos sexos, de entre 6 meses y 12 años de edad (ambos inclusive). 2.Pacientes con un tubo de timpanostomía en el oído que se va a tratar (debe estar presente y abierto). 3. Pacientes que padecen otorrea durante 3 semanas o menos. 4.Otorrea purulenta moderada o intensa en el momento de la inclusión. 5. Consentimiento informado firmado por el representante legal del paciente. Además, el consentimiento para niños firmado por el paciente si el paciente es capaz de proporcionarlo |
|
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 |
1. Inserción del tubo de timpanostomía 3 días o menos antes de la entrada en el estudio. 2. Tubos de timpanostomía con actividad antiséptica o antibacteriana (p. ej., óxido de plata o sales de plata); tubos tipo T. 3. Otitis externa aguda u otitis externa maligna. 4. Sospecha de infección ótica vírica, micótica o micobacteriana. 5. Cirugía otológica durante el año anterior (aparte de la inserción del tubo de timpanostomía). 6. Mastoiditis. 7. Hipersensibilidad diagnosticada o sospechada a quinolonas o corticoides. 8. Antecedentes de un trastorno inmunosupresor, tratamiento inmunosupresor actual o diabetes. 9. Enfermedad renal activa o crónica, o hepatitis activa. 10. Obstrucción nasal crónica o rinorrea persistente. 11. Anomalías craneofaciales. 12. Predisposición a pérdida auditiva neurosensorial*. 13. Uso de fármacos óticos no esteroides por vía tópica el día precedente a la entrada en el estudio. 14. Uso de esteroides tópicos u óticos en los 3 días precedentes a la inclusión, o esteroides sistémicos en los 7 días previos a la inclusión. 15. Uso de esteroides intranasales o inhalados en los 3 días previos a la inclusión 16. Infección que requiera tratamiento antimicrobiano sistémico. 17. Uso de fármacos antimicrobianos o antifúngicos tópicos o sistémicos en los 7 días previos a la entrada en el estudio, o tratamiento antimicrobiano para el episodio actual de OMAT. 18. Uso simultáneo de fármacos antiinflamatorios orales, excepto ibuprofeno (se permite el empleo de analgésicos sin propiedades antiinflamatorias, como paracetamol). 19. Jóvenes menárquicas 20. Participación en otro estudio clínico en los 30 días anteriores. |
|
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. |
Demostrar la superioridad de ciprofloxacino 0,3% más fluocinolona acetónido 0,025% solución ótica en relación con ciprofloxacino 0,3% solución ótica y con fluocinolona acetónido 0,025% solución ótica con respecto al momento en que cese la otorrea. La otorrea se definirá como terminada el primer día en que esté ausente y se mantenga ausente hasta el final del estudio. |
|
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 |
La otorrea será valorada por el investigador en las visitas 1,2,3, y 4. |
|
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. |
El principal criterio secundario de valoración es demostrar la superioridad terapéutica de ciprofloxacino 0,3% más fluocinolona acetónido 0,025% frente a fluocinolona acetónido 0,025% sola, y ciprofloxacino 0,3% solo frente a fluocinolona acetónido 0,025% sola con respecto a la curación microbiológica mantenida |
|
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). |
La muestra para cultivo microbiológico del oído medio se obtendrá en las Visitas 1, 3 y 4 (excepto cuando no haya exudado en la Visita 3 o 4). |
|
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 | 6 |
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 | 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 |
|
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
|
LVLS |
Ultima visita del último paciente |
|
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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
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 |