Efficacy trial of two therapies in Menière´s disease
- Conditions
- In our study we try to evaluate the effect of intratympanic Triamcinolon acetonide and Dexamethason 21-dihydrohenphosphat on vertigo control calculation, Hydrops MRI, vHIT (video head impuls test), caloric testing, audiological examination including discrimination of speech test and on the basis of a quality of life questionnaire.Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]
- Registration Number
- EUCTR2018-001958-10-AT
- Lead Sponsor
- Abteilung für Hals-, Nasen- und Ohrenkrankheiten MUW, AKH Wien
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 20
• Patients, who suffer from „definite Menière´s disease , according to the AAO-HNS guidelines.
• Patients with no retrocochlear or intracerebral pathology on cMRI
• Patients between 18 and 90 years
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
•Patients with severe neurological disorders
•Patients with chronic otitis media
•Patients who were already treated with Gentamicin
•Patients younger than 18 years
•Pregnant and breastfeeding women
•Patients with Contrast agent allergy
•Patients with contraindications against the administration of Triamcinolone acetonide and Dexamethason 21-dihydrogenphosphat
•Patients who take corticoteroids on a regular basis
•Patients with non MRI-compatible implants
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method