*Efficacy and safety of intratympanic dexamethasone compared to intratympanic gentamicin in patients with proven unilateral Ménière*s disease*; a randomised, double-blind, controlled non-inferiority trial

Phase 3

Withdrawn

• Conditions: Meniere's disease; Morbus Meniere; 10022396

• Registration Number: NL-OMON40458
• Lead Sponsor: Gelre Ziekenhuizen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 66

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>We expect a 20% risk difference between the two treatments. A non*inferiority<br /><br>design will be applied with a 10% inferiority margin. If the lower value of the<br /><br>confidence interval of the risk difference is more than 10%, dexamethason will<br /><br>be concluded to be inferior to gentamicin. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Other endpoints are 12 points decrease in Dizziness Handicap Inventory (DHI)<br /><br>score, Tinnitus Handicap Inventory (THI), Pure Tone Audiometry, Speech<br /><br>Discrimination scores, Level of total hearing loss.</p><br>