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

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ClinicalTrials.gov Identifier: NCT00160238
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : December 22, 2006
Sponsor:
Information provided by:
Solvay Pharmaceuticals

September 9, 2005
September 12, 2005
December 22, 2006
January 2003
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Patients who have undergone vestibular neurotomy for the treatment of disabling Menière’s disease and who have confirmed vestibular areflexia
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Complete list of historical versions of study NCT00160238 on ClinicalTrials.gov Archive Site
Other peripheral vestibular disease than Menière’s disease;Central vestibular disease; Neurological disease; Contraindication to betahistine; Pregnant or lactating women
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Effects of Betaserc on Vestibular Compensation in Patients Suffering From Disabling Meniere's Disease and Having Undergone Vestibular Neurotomy
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
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.
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Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Meniere's Disease
Drug: Betahistine 24 mg bid (Betaserc)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
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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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00160238
S108.4.102
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Solvay Pharmaceuticals
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Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
Solvay Pharmaceuticals
December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP