Patients suffering of Menieres disease for at least 6 moths without sufficient relief of symptoms through medicinal therapy MedDRA version: 8.1 Level: LLT Classification code 10027183 Term: Meniere's disease
Conditions
Interventions
Trade Name: gentamicin CF 40 mg/mL for injection
Product Name: gentamicin
Product Code: RVG 57572
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: gentamicin
CAS Number
Sponsors
UMC Utrecht
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Active, unilateral Menieres disease according ti the AAO-HNS guidelines 2. Maximal conservative therapy of at least 6 months without sufficient result 3. Dizziness Handicap Inventory score of at least 30 points 4. Ipsilateral sensorineural hearing loss without large fluctuations 5. Informed consent 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Ipsilateral otologic pathology; 2. Contralateral otologic pathology or profound hearing loss 3. Allergy to aminoglycosides; 4. Prior treatmant with intrtympanal gentamicin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare two different methods of treatment with intratympanical gentamicin in menieres disease. ;Secondary Objective: To compare the effectiveness the both regimes on dizziness. ;Primary end point(s): Dizziness Handicap Inventory (DHI) This is a standerdized questionnaires for patients with dizziness complaints. | — |
Countries
Netherlands
Outcome results
None listed