Intratympanic gentamicin therapy for M Meniere: a comparison of two regimes
- Conditions
- Patients suffering of Menieres disease for at least 6 moths without sufficient relief of symptoms through medicinal therapyMedDRA version: 8.1Level: LLTClassification code 10027183Term: Meniere's disease
- Registration Number
- EUCTR2006-005913-37-NL
- Lead Sponsor
- MC Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
1. Ipsilateral otologic pathology;
2. Contralateral otologic pathology or profound hearing loss
3. Allergy to aminoglycosides;
4. Prior treatmant with intrtympanal gentamicin
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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) <br>This is a standerdized questionnaires for patients with dizziness complaints.<br><br>
- Secondary Outcome Measures
Name Time Method