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 : June 27, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Meniere's Disease | Drug: Methylprednisolone Drug: Gentamicin | Phase 2 Phase 3 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Steroid (Methylprednisolone)
Steroid (Methylprednisolone)
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Drug: Methylprednisolone
2 transtympanic injections at interval of two weeks. |
Active Comparator: Gentamicin
Gentamicin
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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. |
- 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).
- 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.

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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 |
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.

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
United Kingdom | |
Imperial college Healthcare NHS Trust | |
London, United Kingdom |
Principal Investigator: | Adolfo M Bronstein, PhD, FRCP | Imperial College London |
Responsible Party: | Imperial College London |
ClinicalTrials.gov Identifier: | NCT00802529 |
Other Study ID Numbers: |
CRO1135 |
First Posted: | December 5, 2008 Key Record Dates |
Results First Posted: | October 24, 2016 |
Last Update Posted: | June 27, 2019 |
Last Verified: | June 2019 |
Meniere's disease transtympanic steroids Randomised controlled trial |
Meniere Disease Endolymphatic Hydrops Labyrinth Diseases Ear Diseases Otorhinolaryngologic Diseases Gentamicins Methylprednisolone Methylprednisolone Acetate Methylprednisolone Hemisuccinate Prednisolone Prednisolone acetate Prednisolone hemisuccinate Prednisolone phosphate 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 |