Trial Outcomes & Findings for Transtympanic Gentamicin vs. Steroids in Refractory Meniere's Disease (NCT NCT00802529)
NCT ID: NCT00802529
Last Updated: 2019-06-27
Results Overview
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).
COMPLETED
PHASE2/PHASE3
60 participants
6month pre-enrollment baseline, 18-24 months after initial treatment
2019-06-27
Participant Flow
Participant milestones
| Measure |
Steroid (Methylprednisolone)
Methylprednisolone: 2 transtympanic injections at interval of two weeks. Each injection was 62.5mg/ml.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Steroid (Methylprednisolone)
Methylprednisolone: 2 transtympanic injections at interval of two weeks. Each injection was 62.5mg/ml.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Transtympanic Gentamicin vs. Steroids in Refractory Meniere's Disease
Baseline characteristics by cohort
| Measure |
Steroid (Methylprednisolone)
n=30 Participants
Methylprednisolone: 2 transtympanic injections at interval of two weeks.
|
Gentamicin
n=30 Participants
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.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Continuous
|
51.6 Years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
53.3 Years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
52.5 Years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6month pre-enrollment baseline, 18-24 months after initial treatmentPopulation: Intention-to-treat
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).
Outcome measures
| Measure |
Steroid (Methylprednisolone)
n=30 Participants
Methylprednisolone: 2 transtympanic injections at interval of two weeks.
|
Gentamicin
n=29 Participants
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
Baseline
|
16.4 Vertigo Attacks
Standard Deviation 12.45
|
19.93 Vertigo Attacks
Standard Deviation 16.7
|
|
Vertigo Attacks
18-24months
|
1.6 Vertigo Attacks
Standard Deviation 3.4
|
2.5 Vertigo Attacks
Standard Deviation 5.8
|
SECONDARY outcome
Timeframe: Baseline, 1,2,6,12,18 and 24months after initial treatmentHearing 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.
Outcome measures
| Measure |
Steroid (Methylprednisolone)
n=30 Participants
Methylprednisolone: 2 transtympanic injections at interval of two weeks.
|
Gentamicin
n=29 Participants
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.
|
|---|---|---|
|
Change in Hearing
18months
|
48.44 dB
Standard Deviation 22.1
|
44.82 dB
Standard Deviation 18.8
|
|
Change in Hearing
Baseline
|
53.25 dB
Standard Deviation 21.17
|
51.5 dB
Standard Deviation 11.29
|
|
Change in Hearing
1month
|
49.29 dB
Standard Deviation 22.23
|
52.18 dB
Standard Deviation 15.77
|
|
Change in Hearing
2months
|
49.83 dB
Standard Deviation 22.31
|
48.99 dB
Standard Deviation 16.9
|
|
Change in Hearing
6months
|
46.67 dB
Standard Deviation 23.29
|
45.48 dB
Standard Deviation 17.7
|
|
Change in Hearing
12months
|
47.02 dB
Standard Deviation 23.96
|
47.34 dB
Standard Deviation 19.2
|
|
Change in Hearing
24months
|
46.9 dB
Standard Deviation 24.0
|
49.1 dB
Standard Deviation 18.1
|
SECONDARY outcome
Timeframe: Baseline, 1,2,6,12 and 24months after initial treatmentSpeech 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.
Outcome measures
| Measure |
Steroid (Methylprednisolone)
n=30 Participants
Methylprednisolone: 2 transtympanic injections at interval of two weeks.
|
Gentamicin
n=29 Participants
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.
|
|---|---|---|
|
Change in Speech Discrimination
Baseline
|
64.97 Percentage correct
Standard Deviation 29.28
|
72.10 Percentage correct
Standard Deviation 21.67
|
|
Change in Speech Discrimination
1month
|
71.78 Percentage correct
Standard Deviation 26.48
|
69.43 Percentage correct
Standard Deviation 22.94
|
|
Change in Speech Discrimination
2months
|
76.10 Percentage correct
Standard Deviation 24.43
|
74.31 Percentage correct
Standard Deviation 23.4
|
|
Change in Speech Discrimination
6months
|
75.63 Percentage correct
Standard Deviation 26.39
|
76.35 Percentage correct
Standard Deviation 25.92
|
|
Change in Speech Discrimination
12months
|
73.43 Percentage correct
Standard Deviation 27.16
|
71.58 Percentage correct
Standard Deviation 24.69
|
|
Change in Speech Discrimination
24months
|
76.32 Percentage correct
Standard Deviation 29.36
|
64.99 Percentage correct
Standard Deviation 30.75
|
Adverse Events
Steroid (Methylprednisolone)
Gentamicin
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Steroid (Methylprednisolone)
n=30 participants at risk
Methylprednisolone: 2 transtympanic injections at interval of two weeks.
|
Gentamicin
n=32 participants at risk
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.
|
|---|---|---|
|
Ear and labyrinth disorders
Otitis media
|
3.3%
1/30 • Number of events 1
|
6.2%
2/32 • Number of events 2
|
|
Eye disorders
Retinoschisis
|
3.3%
1/30 • Number of events 1
|
0.00%
0/32
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Scwannoma
|
0.00%
0/30
|
3.1%
1/32 • Number of events 1
|
|
Gastrointestinal disorders
Cist
|
3.3%
1/30 • Number of events 1
|
0.00%
0/32
|
Additional Information
Professor Adolfo Bronstein (Clinical professor and Head of neuro-otology group)
Imperial College London
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place