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Transtympanic Gentamicin vs. Steroids in Refractory Meniere's Disease

NCT00802529 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-06-27

Study results available
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Summary

This trial aims to compare transtympanic steroids against the standard treatment (transtympanic gentamicin) in refractory unilateral Meniere's disease.

Conditions

  • Meniere's Disease

Interventions

DRUG

Methylprednisolone

2 transtympanic injections at interval of two weeks.

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.

Sponsors & Collaborators

  • Imperial College Healthcare NHS Trust

    collaborator OTHER

  • Medical Research Council

    collaborator OTHER_GOV

  • Imperial College London

    lead OTHER

Principal Investigators

  • Adolfo M Bronstein, PhD, FRCP · Imperial College London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00802529 on ClinicalTrials.gov