Effectiveness of Transtympanic Steroids in unilateral Ménière's disease: a Randomised Controlled Double-Blind Trial - Transtympanic gentamicin vs. steroids in refractory Ménière's disease

Imperial College London0 sites0 target enrollmentApril 14, 2009

Overview

No summary available.

Registry

who.int

Start Date

April 14, 2009

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Patients with unilateral Ménière's disease (definite or probable, according to AAO\-HNS criteria 1995\) in Shea stages II and III (i.e. with hearing loss and presenting with recurrent vertigo) not responding to medical treatment for at least 6 months will be included.
•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

•a)Patients with Ménière's disease in later stages (not having vertigo attacks).
•b)Age: patients older than 70 years at the start of the trial.
•c)Severe disability (e.g. neurological, orthopaedic, cardiovascular) or serious concurrent illness that might interfere with treatment or follow up.
•d)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.
•e)Concurrent ear pathology that may interfere with TT (e.g. active middle ear disease).
•f)Family history of unexplained deafness (possibility of genetic susceptibility to gentamicin toxicity).
•g)History of known adverse/allergic reaction to steroids or gentamicin.