Trial record 3 of 7 for:
Open Studies | "Meniere Disease"
Transtympanic Gentamicin vs. Steroids in Refractory Meniere's Disease
This study is currently recruiting participants.
Verified September 2011 by Imperial College London
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
First received: December 4, 2008
Last updated: September 29, 2011
Last verified: September 2011
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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 2 Phase 3 |
| 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
Drug Information available for:
Prednisolone
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Prednisolone sodium phosphate
Prednisolone phosphate
Gentamicin
Gentamicin sulfate
Prednisolone sodium succinate
Methylprednisolone sodium succinate
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 hemisuccinate 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 |
ClinicalTrials.gov processed this record on May 22, 2013