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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

December 4, 2008
December 5, 2008
May 9, 2016
October 24, 2016
October 24, 2016
April 2009
May 2015   (Final data collection date for primary outcome measure)
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).
control of vertigo attacks as determined by validated questionnaires and as per committee on hearing and equilibrium guidelines [ Time Frame: acute and long term ]
Complete list of historical versions of study NCT00802529 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.

changes in hearing outcome as determined by hearing tests (Pure Tone Audiometry, Speech Discrimination Scores) [ Time Frame: acute and long term ]
Not Provided
Not Provided
 
Transtympanic Gentamicin vs. Steroids in Refractory Meniere's Disease
Effectiveness of Transtympanic Steroids in Unilateral Ménière's Disease: a Randomised Controlled Double-Blind Trial
This trial aims to compare transtympanic steroids against the standard treatment (transtympanic gentamicin) in refractory unilateral Meniere's disease.
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.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Meniere's Disease
  • Drug: Methylprednisolone
    2 transtympanic injections at interval of two weeks.
  • 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.
  • Experimental: Steroid (Methylprednisolone)
    Intervention: Drug: Methylprednisolone
  • Active Comparator: Gentamicin
    Intervention: Drug: Gentamicin
Patel M, Agarwal K, Arshad Q, Hariri M, Rea P, Seemungal BM, Golding JF, Harcourt JP, Bronstein AM. Intratympanic methylprednisolone versus gentamicin in patients with unilateral Ménière's disease: a randomised, double-blind, comparative effectiveness trial. Lancet. 2016 Dec 3;388(10061):2753-2762. doi: 10.1016/S0140-6736(16)31461-1. Epub 2016 Nov 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
Same as current
May 2015
May 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT00802529
CRO1135
No
Not Provided
Not Provided
Imperial College London
Imperial College London
  • Imperial College Healthcare NHS Trust
  • Medical Research Council
Principal Investigator: Adolfo M Bronstein, PhD, FRCP Imperial College London
Imperial College London
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP