Phase 3
Completed N=60
Transtympanic Gentamicin vs. Steroids in Refractory Meniere's Disease
Source: ClinicalTrials.gov NCT00802529 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcomePrimary: Vertigo Attacks — 16.4; 19.93; 1.6; 2.5 Vertigo Attacks — p=0.271
◆ Published Evidence
Highly cited
167citations · ~17 / year
Intratympanic methylprednisolone versus gentamicin in patients with unilateral Ménière's disease: a randomised, double-blind, comparative effectiveness trial.
Summary
This trial aims to compare transtympanic steroids against the standard treatment (transtympanic gentamicin) in refractory unilateral Meniere's disease.
Linked Publications (2)
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Intratympanic methylprednisolone versus gentamicin in patients with unilateral Ménière's disease: a randomised, double-blind, comparative effectiveness trial.
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Acute unilateral vestibulopathy and corticosteroid treatment - A randomized placebo-controlled double-blind trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Vertigo Attacks |
16.4; 19.93; 1.6; 2.5 | 0.271 |
| SECONDARY Change in Hearing |
53.25; 51.5; 49.29; 52.18; 49.83; 48.99 | 0.964 |
| SECONDARY Change in Speech Discrimination |
64.97; 72.10; 71.78; 69.43; 76.10; 74.31 | 0.128 |
Eligibility Criteria
Inclusion Criteria
- Patients with unilateral Ménière's disease (definite or probable, according to Committee on Hearing and Equilibrium guidelines, 1995) with hearing loss and presenting with recurrent vertigo, not responding to medical treatment for at least 6 months will be included. There should be normal, age appropriate hearing in the contralateral ear.
Exclusion Criteria
- Patients with Ménière's disease in later stages (not having vertigo attacks).
- Age: patients older than 70 years at the start of the trial.
- Severe disability (e.g. neurological, orthopaedic, cardiovascular) or serious concurrent illness that might interfere with treatment or follow up.
- Active additional neuro-otological disorders that may mimic Ménière's disease (e.g. vestibular migraine, vertebro-basilar TIAs, acoustic neuroma) and thus will make the objective follow up difficult.
- Concurrent ear pathology that may interfere with transtympanic treatment (e.g. active middle ear disease).
- Family history of unexplained deafness (possibility of genetic susceptibility to gentamicin toxicity).
- History of known adverse/allergic reaction to steroids or gentamicin.
Data sourced from ClinicalTrials.gov (NCT00802529) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.