NCT00500474

Brief Summary

Meniere's disease is a common inner ear disease with an incidence of 15-50 per 100,000 population. Since Meniere's disease is thought to be triggered by an immune insult to inner ear, we examined intra-endolymphatic sac application of large doses of steroids as de novo treatment for intractable Meniere's disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
197

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 1996

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1996

Completed
8.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 12, 2007

Completed
Last Updated

July 25, 2007

Status Verified

July 1, 2007

First QC Date

July 11, 2007

Last Update Submit

July 23, 2007

Conditions

Meniere's Disease

Keywords

Meniere's diseaseinner earendolymphatic sac drainagesteroidsdeclined surgerynatural courseEfficacy of steroids via endolymphatic sacfor intractable Meniere's disease

Outcome Measures

Primary Outcomes (1)

  • the ratio of patients in vertigo supression and hearing improvement

    post-operative 2-7 years

Secondary Outcomes (1)

  • the ratio of patients in canal improvement

    post-operative 2 years

Interventions

endolymphatic sac drainage with steroidsPROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of Meniere's Disease, who did not respond to various forms of medical and psychological managements for at least 6 months, i.e. intractable Meniere's disease.

You may not qualify if:

  • Other known causes of vertigo including central lesion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Otolaryngology, Osaka University, School of Medicine

Suita, Osaka, 565-0871, Japan

Location

Related Publications (2)

  • Kitahara T, Fukushima M, Uno Y, Mishiro Y, Kubo T. Up-regulation of cochlear aquaporin-3 mRNA expression after intra-endolymphatic sac application of dexamethasone. Neurol Res. 2003 Dec;25(8):865-70. doi: 10.1179/016164103771953989.

    PMID: 14669532BACKGROUND

  • Kitahara T, Horii A, Imai T, Ohta Y, Morihana T, Inohara H, Sakagami M. Effects of endolymphatic sac decompression surgery on vertigo and hearing in patients with bilateral Meniere's disease. Otol Neurotol. 2014 Dec;35(10):1852-7. doi: 10.1097/MAO.0000000000000469.

    PMID: 24979126DERIVED

MeSH Terms

Conditions

Meniere Disease

Interventions

Steroids

Condition Hierarchy (Ancestors)

Endolymphatic HydropsLabyrinth DiseasesEar DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Fused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Tadashi Kitahara, M.D.,Ph.D.

    Department of Otolaryngology, Osaka University, School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 11, 2007

First Posted

July 12, 2007

Study Start

April 1, 1996

Study Completion

March 1, 2005

Last Updated

July 25, 2007

Record last verified: 2007-07

Locations

JP(1)