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Transtympanic Gentamicin vs. Steroids in Refractory Meniere's Disease

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ClinicalTrials.gov Identifier: NCT00802529
Recruitment Status : Completed
First Posted : December 5, 2008
Results First Posted : October 24, 2016
Last Update Posted : October 24, 2016
Sponsor:
Collaborators:
Imperial College Healthcare NHS Trust
Medical Research Council
Information provided by (Responsible Party):
Imperial College London

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

Condition or disease Intervention/treatment Phase
Meniere's Disease Drug: Methylprednisolone Drug: Gentamicin Phase 2 Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Transtympanic Steroids in Unilateral Ménière's Disease: a Randomised Controlled Double-Blind Trial
Study Start Date : April 2009
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

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Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Vertigo Attacks [ Time Frame: 6month pre-enrollment baseline, 18-24 months after initial treatment ]
    The number of vertigo attacks between 18-24months follow-up were taken retrospectively during a face-to-face appointment at 24 months follow-up and compared to 6 month pre-enrollment baseline (as per Committee on Hearing and Equilibrium guidelines).


Secondary Outcome Measures :
  1. Change in Hearing [ Time Frame: Baseline, 1,2,6,12,18 and 24months after initial treatment ]
    Hearing was measured as ipsilesional pure-tone threshold at Baseline, 1month, 2months, 6months, 12month, 18months and 24 months follow-up. Hearing level was taken as the average threshold across 0.5, 1, 2 and 3KHz.

  2. Change in Speech Discrimination [ Time Frame: Baseline, 1,2,6,12 and 24months after initial treatment ]

    Speech discrimination was measured at Baseline, 1month, 2months, 6months, 12month and 24 months follow-up.

    Speech discrimination was assessed by means of ipsilesional suprathreshold word recognition (%). Arthur Boothroyd's isophonemic word lists (AB wordlists, Guymark, Southampton) comprising sets of 10 words were played to the ipsilesional ear at the low-frequency pure-tone threshold of 0·5, 1 and 2 kHz +30dB with masking sound in the contralesional ear if necessary. The formula for masking level was: low-frequency pure-tone threshold in ipsilesional ear - bone conduction mean threshold (0·5, 1 and 2KHz) in contralesional ear - 40dB. Speech loudness and masking were rounded to the nearest 5dB. Step increments and decrements of 10dB for speech loudness and masking were used to attain the maximum speech discrimination score.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00802529


Locations
United Kingdom
Imperial college Healthcare NHS Trust
London, United Kingdom
Sponsors and Collaborators
Imperial College London
Imperial College Healthcare NHS Trust
Medical Research Council
Investigators
Principal Investigator: Adolfo M Bronstein, PhD, FRCP Imperial College London
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT00802529     History of Changes
Other Study ID Numbers: CRO1135
First Posted: December 5, 2008    Key Record Dates
Results First Posted: October 24, 2016
Last Update Posted: October 24, 2016
Last Verified: February 2016

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
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Gentamicins
Anti-Inflammatory Agents
Antiemetics
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors