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
About this trial
This is an interventional treatment trial for Meniere's Disease focused on measuring Meniere's disease, Vestibular neurotomy
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
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
NCT ID
NCT00160238
First Posted
September 9, 2005
Last Updated
December 21, 2006
Sponsor
Solvay Pharmaceuticals
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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