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
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Experimental: Steroid (Methylprednisolone)||
2 transtympanic injections at interval of two weeks.
|Active Comparator: 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.
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
|Imperial college Healthcare NHS Trust|
|London, United Kingdom|
|Principal Investigator:||Adolfo M Bronstein, PhD, FRCP||Imperial College London|