Status:
COMPLETED
Transtympanic Gentamicin vs. Steroids in Refractory Meniere's Disease
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
Imperial College Healthcare NHS Trust
Medical Research Council
Conditions:
Meniere's Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
Brief Summary
This trial aims to compare transtympanic steroids against the standard treatment (transtympanic gentamicin) in refractory unilateral Meniere's disease.
Detailed Description
Meniere's disease is characterised by episodic spontaneous vertigo attacks with hearing loss, ringing sounds and fullness in the ear. In one out of five patients, standard first line medical treatment...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00802529
Start Date
April 1 2009
End Date
May 1 2015
Last Update
June 27 2019
Active Locations (1)
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1
Imperial college Healthcare NHS Trust
London, United Kingdom