DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Transtympanic Gentamicin vs. Steroids in Refractory Meniere's Disease

Information source: Imperial College London
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Meniere's Disease

Intervention: Methylprednisolone (Drug); Gentamicin (Drug)

Phase: Phase 2/Phase 3

Status: Active, not recruiting

Sponsored by: Imperial College London

Official(s) and/or principal investigator(s):
Adolfo M Bronstein, PhD, FRCP, Principal Investigator, Affiliation: Imperial College London

Summary

This trial aims to compare transtympanic steroids against the standard treatment (transtympanic gentamicin) in refractory unilateral Meniere's disease.

Clinical Details

Official title: Effectiveness of Transtympanic Steroids in Unilateral Ménière's Disease: a Randomised Controlled Double-Blind Trial

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: control of vertigo attacks as determined by validated questionnaires and as per committee on hearing and equilibrium guidelines

Secondary outcome: changes in hearing outcome as determined by hearing tests (Pure Tone Audiometry, Speech Discrimination Scores)

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 is not effective in controlling vertigo attacks. For these incapacitated patients, gentamicin injections through the ear drum is a well established minimally invasive treatment. Major surgery of the balance organs or nerve, risking complete hearing loss, CSF leak, meningeal infections, are rarely performed nowadays. Gentamicn is very effective in controlling vertigo and acts by chemical ablation of end organs. As hearing and balance organs are entwined around each other, gentamicin treatment does not come without the risk of hearing loss. In fact, meta-analysis shows hearing deterioration in 13% to 35% percent of gentamicin treated patients. On the other hand, steroids are drug of choice for autoimmune inner ear disease and commonly used for sudden hearing loss. They are non toxic drugs without any known side effects during local treatment in ear. We will compare the two in this randomised, double blind trial.

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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.

Locations and Contacts

Imperial college Healthcare NHS Trust, London, United Kingdom
Additional Information

Starting date: April 2009
Last updated: September 16, 2013

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017