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

This study has been completed.

Sponsored by:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00160238

Purpose

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.

Condition	Intervention	Phase
Meniere's Disease	Drug: Betahistine 24 mg bid (Betaserc)	Phase IV

MedlinePlus related topics: Meniere's Disease

Drug Information available for: Betahistine Betahistine dihydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Solvay Pharmaceuticals:

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

Estimated Enrollment:	20
Study Start Date:	January 2003

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00160238

Locations

France
Site 1
Marseille, France

Sponsors and Collaborators

Solvay Pharmaceuticals

Investigators

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

More Information

Study ID Numbers:	S108.4.102
Study First Received:	September 9, 2005
Last Updated:	December 21, 2006
ClinicalTrials.gov Identifier:	NCT00160238
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Solvay Pharmaceuticals:

Meniere's disease
Vestibular neurotomy

Study placed in the following topic categories:

Otorhinolaryngologic Diseases
Meniere Disease
Histamine phosphate
Edema

Betahistine
Ear Diseases
Histamine

Additional relevant MeSH terms:

Vasodilator Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Histamine Agonists
Therapeutic Uses
Endolymphatic Hydrops

Physiological Effects of Drugs
Histamine Agents
Cardiovascular Agents
Pharmacologic Actions
Labyrinth Diseases

ClinicalTrials.gov processed this record on January 16, 2009