Trial · NCT00802529

Transtympanic Gentamicin vs. Steroids in Refractory Meniere's Disease

NCT00802529, Phase 2, Phase 3, Completed, Imperial College London; results first posted 2016-10-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Transtympanic Gentamicin vs. Steroids in Refractory Meniere's Disease. Trials, record NCT00802529. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00802529

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Transtympanic Gentamicin vs. Steroids in Refractory Meniere's Disease
NCT number: NCT00802529
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 60 participants, actual
Lead sponsor: Imperial College London
Conditions: Meniere's Disease
Interventions: Methylprednisolone, Gentamicin
First posted: 2008-12-05
Last updated: 2019-06-27
Results first posted: 2016-10-24

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Vertigo Attacks	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).
Secondary	Change in Hearing	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.
Secondary	Change in Speech Discrimination	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.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Vertigo Attacks	6month pre-enrollment baseline, 18-24 months after initial treatment	Intention-to-treat	Vertigo Attacks	MEAN
SECONDARY	Change in Hearing	Baseline, 1,2,6,12,18 and 24months after initial treatment		dB	MEAN
SECONDARY	Change in Speech Discrimination	Baseline, 1,2,6,12 and 24months after initial treatment		Percentage correct	MEAN

Source ClinicalTrials.gov

Results by group30

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Vertigo Attacks	Steroid (Methylprednisolone)	Baseline	16.4	Standard Deviation 12.45	Vertigo Attacks
Vertigo Attacks	Gentamicin	Baseline	19.93	Standard Deviation 16.7	Vertigo Attacks
Vertigo Attacks	Steroid (Methylprednisolone)	18-24months	1.6	Standard Deviation 3.4	Vertigo Attacks
Vertigo Attacks	Gentamicin	18-24months	2.5	Standard Deviation 5.8	Vertigo Attacks
Change in Hearing	Steroid (Methylprednisolone)	Baseline	53.25	Standard Deviation 21.17	dB
Change in Hearing	Gentamicin	Baseline	51.5	Standard Deviation 11.29	dB
Change in Hearing	Steroid (Methylprednisolone)	1month	49.29	Standard Deviation 22.23	dB
Change in Hearing	Gentamicin	1month	52.18	Standard Deviation 15.77	dB
Change in Hearing	Steroid (Methylprednisolone)	2months	49.83	Standard Deviation 22.31	dB
Change in Hearing	Gentamicin	2months	48.99	Standard Deviation 16.9	dB

1 to 10 of 30Source ClinicalTrials.gov

See all 30 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Steroid (Methylprednisolone)	30
Overall Study	STARTED	Gentamicin	30
Overall Study	COMPLETED	Steroid (Methylprednisolone)	30
Overall Study	COMPLETED	Gentamicin	29
Overall Study	NOT COMPLETED	Steroid (Methylprednisolone)	0
Overall Study	NOT COMPLETED	Gentamicin	1

Source ClinicalTrials.gov

Adverse events8

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Otitis media	Ear and labyrinth disorders	Steroid (Methylprednisolone)	1	30	1
other	Otitis media	Ear and labyrinth disorders	Gentamicin	2	32	2
other	Retinoschisis	Eye disorders	Steroid (Methylprednisolone)	1	30	1
other	Retinoschisis	Eye disorders	Gentamicin	0	32	0
other	Scwannoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Steroid (Methylprednisolone)	0	30	0
other	Scwannoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Gentamicin	1	32	1
other	Cist	Gastrointestinal disorders	Steroid (Methylprednisolone)	1	30	1
other	Cist	Gastrointestinal disorders	Gentamicin	0	32	0

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Steroid (Methylprednisolone)	0	30
Total, all-cause mortality	Gentamicin	0	32
Total, other adverse events	Steroid (Methylprednisolone)	3	30
Total, other adverse events	Gentamicin	3	32
Total, serious adverse events	Steroid (Methylprednisolone)	0	30
Total, serious adverse events	Gentamicin	0	32

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
27865535	DERIVED	PubMed
39973595	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Steroid (Methylprednisolone) vs Gentamicin: deaths from any cause	Trial comparisons
Steroid (Methylprednisolone) vs Gentamicin: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00802529

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API reference For AI assistants