E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
In this study triamcinolone acetonide levels after intratympanic application in the perilymph, and serum of patients receiving a cochlear implant will be studied. In patients undergoing a translabyrinthine approach to the internal auditory canal with a simultaneous cochlear Implantation additional samples of the perilymphatic fluid at the semiciruclar canal and of cerebrospinal fluid will be taken. Triamcinolone acetonide should have an otoprotective effect. |
In dieser Studie sollen Triamcinolonacetonid Spiegel in der Perilymphe, dem Serum und im Liquor bestimmt werden im Rahmen einer Cochlea Implantation. Bei Patienten, die einem translabyrinthären Zugang zum inneren Gehörgang unterzogen werden mit Cochlea Implantation wird der Triamcinolonacetonidspiegel in die Perilymphe des Bogengangs und im Liquor bestimmt. Triamcinolonacetonid soll eine otoprotektive Wirkung haben. |
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E.1.1.1 | Medical condition in easily understood language |
In this study patients undergoing surgery for a hearing implant will be included and levels of triamcinolone acetonide will be determined in the inner ear liquid, blood and cerebrospinal fluid. |
In dieser Studie werden Patienten, die Hörimplantat erhalten sollen untersucht. Bei diesen Patienten werden Triamcinolonacetonid Spiegel in der Innenohrflüssigkeit, im Blut und im Liquor untersucht. |
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E.1.1.2 | Therapeutic area | Body processes [G] - Chemical Phenomena [G02] |
MedDRA Classification |
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 |
Primary Objective Demonstrate absorption of Triamcinolone acetonide in cochlear perilymph in comparison to dissemination to the blood circulation after intratympanic application
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Primäres Ziel der Studie:
Berechnung der Triamcinolonacetonid Spiegel in der Perilymphe im Vergleich zu Serumwerten nach intratympanaler Applikation |
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E.2.2 | Secondary objectives of the trial |
Secondary Objectives • Assess the stability of triamcinolone acetonide levels in the cochlear perilymph • Assess perilymph concentrations and blood concentrations of triamcinolone acetonide after administration of different triamcinolone doses. • Assess triamcinolone acetonide levels in comparison in the perilymphatic fluid at the round window and at the semicircular canal • Assess the transfer of triamcinolone acetonide to cerebrospinal fluid |
Sekundäre Ziele der Studie
Evaluation der Stabilität von Triamcinolon acetonide Spiegeln in der Perilymphe Vergleich der Triamcinolon Spiegel im Serum und in der Perilymphe nach Applikation von unterschiedlichen Dosen von Triamcinolonacetonid Evaluation der Perilymphspiegel von Triamcinolonacetonid am runden Fenster und im Bogengang. Evaluation der Übertragung von Triamcinolonacetonid in den Liquor. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients between 18 and 90 years will be included in the study, who will undergo a cochlear implantation and are willing to participate in the study or patients undergoing a translabyrintihne Approach to the internal auditory canal with simultaneous cochlear Implantation. |
Patienten zwischen 18 und 90 Jahren, welche vor einer Cochlea Implantation stehen und bereit sind an der Studie teilzunehmen oder Patienten die über einen translabyrinthären zugang am inneren Gehörgang operiert werden und gleichzeitig eine Cochlea Implantation erhalten. |
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E.4 | Principal exclusion criteria |
Patients younger than 18 years . Patients who receive cortison on a regular level or receive cortison i.v. or p.o. preoperatively . Patients with contraindications against the administration of Volon A |
Patienten die jünger sind als 18 Jahre. Patienten, welche regelmässig Kortisonpärparate einnehmen müssen oder direkt präoperativ einmalig intravenös oder per os Kortison erhalten haben. Patienten bei denen es eine Kontraindikationen gegen die Verabreichung von Volon A gibt. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Levels of Triamcinolone actinide in cochlear perilymph, blood and cerebrospinal fluid |
Triamcinolonacetonidspiegel in der Perilymphe, im Blut und im Liquor |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At the end of the study the Triamcinolone acetonide levels will be determined in the perilymph, the blood and cerebrospinal fluid. |
Am Ende der Studien werden die Konzentrationsspiegel von Triamcinolonacetonid der Perilymphe, des Blutes und im Liquor. |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
not applicable |
not applicable |
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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 | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | No |
E.8.2.4 | Number of treatment arms in the trial | 5 |
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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LVLS |
Letzte Kontrolle des letzten Patienten |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |