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| Name | Class |
|---|---|
| Imperial College Healthcare NHS Trust | OTHER |
| Medical Research Council | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Steroid (Methylprednisolone) | Experimental | Steroid (Methylprednisolone) |
|
| Gentamicin | Active Comparator | Gentamicin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylprednisolone | Drug | 2 transtympanic injections at interval of two weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vertigo Attacks | 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). | 6month pre-enrollment baseline, 18-24 months after initial treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hearing | 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. | Baseline, 1,2,6,12,18 and 24months after initial treatment |
| Change in Speech Discrimination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adolfo M Bronstein, PhD, FRCP | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial college Healthcare NHS Trust | London | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39973595 | Derived | Sjogren J, Fransson PA, Magnusson M, Karlberg M, Tjernstrom F. Acute unilateral vestibulopathy and corticosteroid treatment - A randomized placebo-controlled double-blind trial. J Vestib Res. 2025 Mar;35(2):91-101. doi: 10.1177/09574271241307649. Epub 2024 Dec 18. | |
| 27865535 | Derived | 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 Meniere'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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Steroid (Methylprednisolone) | Methylprednisolone: 2 transtympanic injections at interval of two weeks. Each injection was 62.5mg/ml. |
| FG001 | Gentamicin | 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.Each injection was 40mg/ml. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Steroid (Methylprednisolone) | Methylprednisolone: 2 transtympanic injections at interval of two weeks. |
| BG001 | Gentamicin | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Vertigo Attacks | 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). | Intention-to-treat | Posted | Mean | Standard Deviation | Vertigo Attacks | 6month pre-enrollment baseline, 18-24 months after initial treatment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Steroid (Methylprednisolone) | Methylprednisolone: 2 transtympanic injections at interval of two weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Otitis media | Ear and labyrinth disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Adolfo Bronstein (Clinical professor and Head of neuro-otology group) | Imperial College London | (0)20 3313 5525 | +44 | a.bronstein@imperial.ac.uk |
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| ID | Term |
|---|---|
| D008575 | Meniere Disease |
| ID | Term |
|---|---|
| D018159 | Endolymphatic Hydrops |
| D007759 | Labyrinth Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| D005839 | Gentamicins |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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| Gentamicin | Drug | 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. |
|
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. |
| Baseline, 1,2,6,12 and 24months after initial treatment |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Change in Hearing | 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. | Posted | Mean | Standard Deviation | dB | Baseline, 1,2,6,12,18 and 24months after initial treatment |
|
|
|
|
| Secondary | Change in Speech Discrimination | 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. | Posted | Mean | Standard Deviation | Percentage correct | Baseline, 1,2,6,12 and 24months after initial treatment |
|
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 3 |
| 30 |
| EG001 | Gentamicin | 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. | 0 | 32 | 0 | 32 | 3 | 32 |
| Retinoschisis | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Scwannoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Non-systematic Assessment |
|
| Cist | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
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| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| 2months |
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| 6months |
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| 12months |
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| 18months |
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| 24months |
|
| 2months |
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| 6months |
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| 12months |
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| 24months |
|