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 cerebrospinal fluid will be studied. Patients undergoing surgery with dura access will be asked to participate. Patients will receive triamcinolone acetonide applied intratympanically. During surgery a sample of cerebrospinal fluid will be recovered for analysis |
In dieser Studie sollen Triamcinolonacetonid Spiegel im Liquor bestimmt werden im Rahmen von Operationen, bei denen die Dura eröffnet wird. Patienten die einer solchen Operation unterzogen werden, werden nach ihrer Einwilligung eingeschlossen. Diese Patienten erhalten Triamcinolonacetonid intratympanal. Intraoperativ wird eine Probe Liquor entnommen und anschließend untersucht. |
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E.1.1.1 | Medical condition in easily understood language |
In this study levels of triamcinolone acetonide, which is applied directly to the middle ear, will be analyzed in cerebrospinal fluid. |
In dieser Studie soll der Medikamentenspiegel von Triamcinolonacetonid, welches ins Mittelohr gespritzt wird, im Liquor (Gehirnflüssigkeit) untersucht werden. |
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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 presence of Triamcinolone acetonide in cerebrospinal fluid
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Primäres Ziel der Studie:
Nachweis von Triamcinolonacetonid im Liquor |
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E.2.2 | Secondary objectives of the trial |
Secondary Objectives • Correlation of timing of application with triamcinolone acetonide levels in cerebrospinal fluid • Assess the relationship of size of cochlear aqueduct (on CT) and triamcinolone level
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Sekundäre Ziele der Studie
Evaluation der Korrelation des Applikationszeitpunkts mit dem Triamcinolon acetonide Spiegeln im Liquor Relation der Größe des cochleären Aquädukt und der Triamcinolonspiegel im 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, who are willing to participate in the study, will be included Patient who will undergo a surgery with opening of the dura and access to cerebrospinal fluid will be asked to participate in the study. |
Patienten zwischen 18 und 90 Jahren, welche eine Operation erhalten mit Eröffnung der Dura und Zugang zum Liquor, die mit dem Studieneinschluss einverstanden sind werden eingeschlossen. |
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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 acetonide in cerebrospinal fluid |
Triamcinolonacetonidspiegel 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 cerebrospinal fluid. |
Am Ende der Studien werden die Konzentrationsspiegel von Triamcinolonacetonid im Liquor bestimmt. |
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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 | 1 |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |