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Effects of Betaserc on Vestibular Compensation in Patients Suffering From Disabling Meniere's Disease and Having Undergone Vestibular Neurotomy

Primary Purpose

Meniere's Disease

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Betahistine 24 mg bid (Betaserc)
Sponsored by
Solvay Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meniere's Disease focused on measuring Meniere's disease, Vestibular neurotomy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients who have undergone vestibular neurotomy for the treatment of disabling Menière's disease and who have confirmed vestibular areflexia Exclusion Criteria: Other peripheral vestibular disease than Menière's disease Central vestibular disease Neurological disease Contraindication to betahistine Pregnant or lactating women

Sites / Locations

  • Site 1

Outcomes

Primary Outcome Measures

Patients who have undergone vestibular neurotomy for the treatment of disabling Menière's disease and who have confirmed vestibular areflexia

Secondary Outcome Measures

Other peripheral vestibular disease than Menière's disease;Central vestibular disease; Neurological disease; Contraindication to betahistine; Pregnant or lactating women

Full Information

First Posted
September 9, 2005
Last Updated
December 21, 2006
Sponsor
Solvay Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00160238
Brief Title
Effects of Betaserc on Vestibular Compensation in Patients Suffering From Disabling Meniere's Disease and Having Undergone Vestibular Neurotomy
Official Title
A Double-Blind, Placebo-Controlled, Randomized, Clinical Study of the Effects of Betaserc® 24 mg (1 Tablet b.i.d Over 3 Months) on Vestibular Compensation Following Vestibular Neurotomy in Patients With Disabling Menière's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
December 2006
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Solvay Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
This study is to compare the effects of Betaserc 24mg and placebo on compensation of postural and locomotor deficits (static and dynamic posturography) after vestibular neurotomy in patients suffering from disabling Menière's disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meniere's Disease
Keywords
Meniere's disease, Vestibular neurotomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Betahistine 24 mg bid (Betaserc)
Primary Outcome Measure Information:
Title
Patients who have undergone vestibular neurotomy for the treatment of disabling Menière's disease and who have confirmed vestibular areflexia
Secondary Outcome Measure Information:
Title
Other peripheral vestibular disease than Menière's disease;Central vestibular disease; Neurological disease; Contraindication to betahistine; Pregnant or lactating women

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who have undergone vestibular neurotomy for the treatment of disabling Menière's disease and who have confirmed vestibular areflexia Exclusion Criteria: Other peripheral vestibular disease than Menière's disease Central vestibular disease Neurological disease Contraindication to betahistine Pregnant or lactating women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Director Solvay
Organizational Affiliation
Solvay Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Site 1
City
Marseille
Country
France

12. IPD Sharing Statement

Learn more about this trial

Effects of Betaserc on Vestibular Compensation in Patients Suffering From Disabling Meniere's Disease and Having Undergone Vestibular Neurotomy

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