Transtympanic Gentamicin vs. Steroids in Refractory Meniere's Disease - Full Text View

Sponsor:	Imperial College London
Collaborators:	Meniere's Society Imperial College Healthcare NHS Trust Medical Research Council
Information provided by (Responsible Party):	Imperial College London
ClinicalTrials.gov Identifier:	NCT00802529

Purpose

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

Condition	Intervention	Phase
Meniere's Disease	Drug: Methylprednisolone Drug: Gentamicin	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Effectiveness of Transtympanic Steroids in Unilateral Ménière's Disease: a Randomised Controlled Double-Blind Trial

Resource links provided by NLM:

Genetics Home Reference related topics: Ménière disease

MedlinePlus related topics: Dizziness and Vertigo Meniere's Disease

Drug Information available for: Prednisolone Prednisolone acetate Depo-medrol Medrol veriderm Methylprednisolone Prednisolone sodium phosphate Gentamicins Prednisolone Sodium Succinate Methylprednisolone Sodium Succinate Methylprednisolone hemisuccinate 6-Methylprednisolone

U.S. FDA Resources

Further study details as provided by Imperial College London:

Primary Outcome Measures:

control of vertigo attacks as determined by validated questionnaires and as per committee on hearing and equilibrium guidelines [ Time Frame: acute and long term ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

changes in hearing outcome as determined by hearing tests (Pure Tone Audiometry, Speech Discrimination Scores) [ Time Frame: acute and long term ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	April 2009
Estimated Study Completion Date:	September 2013
Estimated Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Steroid (Methylprednisolone)	Drug: Methylprednisolone 2 transtympanic injections at interval of two weeks.
Active Comparator: Gentamicin	Drug: Gentamicin 2 transtympanic injections at an interval of two weeks. If there is significant hearing loss before second injection, it will be replaced by normal saline in double blinded fashion.

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

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00802529

Contacts

Contact: Mitesh Patel, PhD	020 3311 7349	Mitesh.Patel1@imperial.ac.uk
Contact: Adolfo M Bronstein, PhD, FRCP	020 3313 5525	a.bronstein@imperial.ac.uk

Locations

United Kingdom
Imperial college Healthcare NHS Trust	Recruiting
London, United Kingdom
Principal Investigator: Adolfo M Bronstein, PhD, FRCP

Sponsors and Collaborators

Imperial College London

Meniere's Society

Imperial College Healthcare NHS Trust

Medical Research Council

Investigators

Principal Investigator:

Adolfo M Bronstein, PhD, FRCP

Imperial College London

More Information

No publications provided

Responsible Party:	Imperial College London
ClinicalTrials.gov Identifier:	NCT00802529 History of Changes
Other Study ID Numbers:	CRO1135
Study First Received:	December 4, 2008
Last Updated:	September 29, 2011
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Imperial College London:

Meniere's disease
transtympanic steroids
Randomised controlled trial

Additional relevant MeSH terms:

Meniere Disease
Endolymphatic Hydrops
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Gentamicins
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone phosphate
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses

Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Glucocorticoids
Hormones

ClinicalTrials.gov processed this record on February 09, 2012