E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic otitis |
Otite Cronica |
|
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 | 10033081 |
E.1.2 | Term | Otitis media chronic |
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 |
To Assess Kedrion Fibrin Sealant Efficacy in the restoring of normal tympanic anatomy. |
Dimostrare l’efficacia sigillante/adesiva della Colla di Fibrina Kedrion, nel ripristino della normale anatomia timpanica (chiusura della perforazione a 3 settimane ± 3 gg lavorativi dall’intervento), in pazienti sottoposti ad interventi di microchirurgia dell’orecchio medio. |
|
E.2.2 | Secondary objectives of the trial |
Efficacy evaluation of IMP for:
1. deficit auditive recovery
2. topic therapy.
Safety and tollerability evaluation of IMP |
• Valutare l’efficacia dell’IMP in termini di: 1. recupero del deficit uditivo; 2. necessita' di terapie topiche (cortisonici e/o antibiotici). Valutare la sicurezza e la tollerabilita' dell’IMP. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Age > 18 years; 2. Ear Microsurgery for middle simple chronic otitis; 3. The subjects or their authorised legal representatives must have received all necessary information as regards the nature of the clinical study, they must agree with the purpose of the study and must have signed and dated the informed consent form approved by the EC. |
1. Eta' maggiore di 18 anni; 2. Soggetti sottoposti ad interventi di microchirurgia dell’orecchio per otite media cronica semplice (perforazione della membrana timpanica); 3. I soggetti o i rappresentanti legali autorizzati devono aver ricevuto adeguate informazioni in merito alla natura della sperimentazione, essere d’accordo con gli scopi dello studio e aver firmato il modulo del consenso informato ed il modulo di autorizzazione al trattamento dei dati personali approvati dal Comitato Etico (CE). |
|
E.4 | Principal exclusion criteria |
1.Use of other adhesive/sealant agents; 2.Presence of conditions that, at the discretion of the Investigator, may interfere with the assessment of the study’s purpose or with participation in the study; 3. Previous use of products with aprotinine bovine (less than 12 months); 4. Known allergies to one or more components (aprotinin) of the IMP and/or other blood derivatives; 5. Concomitant debilitating deseases (diabetes, immunological and ematological deseases); 6.Missing written consent form required for participation in the study; 7.Participation in another clinical study in the month preceding the start of the study (i.e. in the last 30 days, the subject has taken other trial drugs); 8. Pregnancy |
1. Utilizzo di altri agenti adesivi/sigillanti non previsti dal protocollo; 2. Presenza di condizioni che, a giudizio dello sperimentatore, potrebbero interferire con la valutazione dell’obiettivo dello studio o con la partecipazione allo studio; 3. Precedente esposizione a prodotti contenenti aprotinina bovina da meno di 12 mesi; 4. Allergie note ad emoderivati e/o ad emocomponenti; 5. Presenza di malattie debilitanti (diabete, malattie immunologiche ed ematologiche); 6. Mancanza di consenso informato e di modulo di autorizzazione al trattamento dei dati personali, datati e firmati dal paziente o dal rappresentante legale; 7. Partecipazione ad un altro studio clinico nel mese precedente l’inizio dello studio (negli ultimi 30 giorni il soggetto ha assunto altri farmaci sperimentali). 8. Soggetti in gravidanza. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
To Assess Kedrion Fibrin Sealant Efficacy in the restoring of normal tympanic anatomy. |
Dimostrare l’efficacia sigillante/adesiva della Colla di Fibrina Kedrion, nel ripristino della normale anatomia timpanica (chiusura della perforazione a 3 settimane ± 3 gg lavorativi dall’intervento), in pazienti sottoposti ad interventi di microchirurgia dell’orecchio medio. |
|
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) | Yes |
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 | Yes |
E.8.1.4 | Double blind | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
|
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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
| |
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 | 21 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 21 |