To compare the effect of IT dexamethasone versus IT gentamicin on number and severity vertigo attacks.To compare the effects of IT dexamethasone with IT gentamicin on hearing function, functional level scale and aural fullness.
ID
Source
Brief title
Condition
- Inner ear and VIIIth cranial nerve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
We expect a 20% risk difference between the two treatments. A non*inferiority
design will be applied with a 10% inferiority margin. If the lower value of the
confidence interval of the risk difference is more than 10%, dexamethason will
be concluded to be inferior to gentamicin.
Secondary outcome
Other endpoints are 12 points decrease in Dizziness Handicap Inventory (DHI)
score, Tinnitus Handicap Inventory (THI), Pure Tone Audiometry, Speech
Discrimination scores, Level of total hearing loss.
Background summary
There is no established treatment for Ménière's disease, nor agreement on
whether Ménière's disease is a single clinical entity or an umbrella syndrome
covering different aetiologies and pathophysiological mechanisms. Lately, IT
treatments have been advocated and IT gentamicin injections have been
established for refractory attacks of vertigo in Ménière's disease.
This treatment however carries an inherent risk of aggravating the hearing loss
and alternatives have been sought. Of these, local treatment with steroids has
shown to be promising in that no hearing deterioration is expected and indeed
some studies report improvement in hearing.
Study objective
To compare the effect of IT dexamethasone versus IT gentamicin on number and
severity vertigo attacks.
To compare the effects of IT dexamethasone with IT gentamicin on hearing
function, functional level scale and aural fullness.
Study design
Randomised, double-blind, controlled, non-inferiority multicenter study
Intervention
Dexamethasone (20 mg/ml ) 0,5 * 0,6 ml or gentamicin (40 mg/ ml) 0.5 ml * 0,6
ml.
Patients receive two injections within two weeks.
Study burden and risks
Patients will visit the hospital five times for study purposes.
The treatment phase will be two weeks and the follow-up phase will be 24 months
after the last IT injection.
Follow up visits will be performed at six months, 12 months and 24 months.
During participation there will be several safety tests.
In both treatment groups, there is a small chance of pain, short-lasting
vertigo, otitis media, and membrane perforation after intratympanic injection.
There is a risk of hearing loss with gentamicin therapy.
The potential advantage of intratympanic steroid therapy is the beneficial
effect on hearing when compared to gentamicin therapy.
Following the risk classification scheme of the Nederlandse Federatie van
Universitair Medische Centra (NFU) the risk for participation in this trial is
negligible.
The safety risk for patients in both groups is the same as in normal clinical
practice. For IT gentamicin the risk hearing loss of ca. 20%, but even during
the use of dexamethasone, there is a possibility of hearing loss due to the
natural course of M. Ménière. It is unpredictable in which patient hearing loss
will occur.
In both groups there is a risk of ineffectiveness of vertigo control and a
small risk of infection, temporary pain, discomfort.
The risk and burden for the subjects is in proportion to the potential value of
the research.
At this moment there are no unknown risks.
Albert Schweitzerlaan 31
Apeldoorn 7334 DZ
NL
Albert Schweitzerlaan 31
Apeldoorn 7334 DZ
NL
Listed location countries
Age
Inclusion criteria
*Definite unilateral Ménière's disease according to AAO-HNS criteria: two or more definitive spontaneous episodes of vertigo for at least 20 minutes, AND audiometric confirmation of a sensorineural hearing loss, AND tinnitus (other causes excluded)
*Not responding to oral medical treatment for at least six months.
*Age above 18 years at the start of the trial.
*Willing to adhere to the follow up assessments.
Exclusion criteria
*Ménière's disease in advanced stages (not having vertigo attacks).
*bilateral Ménière's disease.
*Severe disability (e.g. neurological, orthopaedic, cardiovascular) or serious concurrent illness that might interfere with treatment or follow up.
*Active additional neuro-otologic disorders that may mimic Ménière's disease (e.g. vestibular migraine, vertebro-basilar TIAs, acoustic neuroma).
*Concurrent ear pathology that may interfere with IT injections (e.g. active middle ear disease).
*Family history of unexplained deafness (possibility of genetic susceptibility to gentamicin toxicity).
*History of known adverse and/or allergic reaction to steroids or gentamicin.
*Women of child bearing age not using contraception, pregnant women or nursing women.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2013-004086-14-NL |
| CCMO | NL46537.041.13 |