Effectiveness of Betaserc® (Betahistine Dihydrochloride) in Patients With Vestibular Vertigo in Routine Practice

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

309 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-05-31

Brief Summary

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The purposes of this international post-marketing observational program is to investigate effectiveness of betahistine dihydrochloride (Betaserc®) tablets and assess the course of vestibular vertigo after treatment discontinuation in population of Russia and Ukraine outpatients suffering from vestibular vertigo in pragmatic clinical settings. Exploratory analyses of results from both participating countries may be expected to provide insights about the subjective circumstances of vestibular vertigo patients in a wider than usual range of gender, underlying ICD-10 diagnosis, national and cultural situations.

Detailed Description

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A prospective, multicentre, non-interventional, non-randomized, non-controlled, single arm, post-marketing observational program in patients whom betahistine dihydrochloride (Betaserc®) tablets were prescribed in the usual manner at the maximal recommended daily dose of 48 mg in accordance with the locally approved label. Over a program period physician is free to adjust betahistine dihydrochloride dose according to country approved label. Adult outpatients with vestibular vertigo who can be treated with betahistine dihydrochloride as per the locally approved label will be enrolled in the program. The program consists of an observational treatment period (up to 2 months) and a follow-up period (up to 2 months, for evaluation of the course of vestibular vertigo after treatment completion).

Conditions

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Vertigo

Keywords

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Meniere Disease Betahistine Dihydrochloride Vertigo

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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vestibular vertigo

Patients with vestibular vertigo of known or unknown origin, and for whom the physician has decided to prescribe betahistine dihydrochloride at dose 48 mg/day in accordance with locally approved label

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Male or female 18 years and older.
* Patients with vestibular vertigo of known or unknown origin, and for whom the physician has decided to prescribe 48 mg of betahistine dihydrochloride (Betaserc®) in accordance with locally approved label.
* Patients who are willing and able to provide authorization to the investigator to use and/or disclose personal and/or health data.
* Patients who started betahistine dihydrochloride (Betaserc®) therapy not more than 5 days priory to sign Patient Authorization (Consent) for Use/Disclosure of Data.

Exclusion Criteria

* Patients with any condition which, in the opinion of the Investigator, makes the patient unsuitable for inclusion based on clinical judgment.
* Labeled contraindications of betahistine dihydrochloride (Betaserc®) treatment.
* Patients with middle or inner ear infection.
* Patient with psychiatric disorders, significant neurological disorder or spinal cord damage.
* Patients receiving any other agents for peripheral vestibular vertigo such as diuretics, transtympanic gentamycin, cinnarizine, competitive antagonist of histamine, blocking H1- histamine receptors.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Pascal Berrou, MD

Role: STUDY_DIRECTOR

Abbott

Zaporizhzhia, , Ukraine

Site Status

Countries

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Russia Ukraine

Other Identifiers

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P13-972

Identifier Type: -

Identifier Source: org_study_id

Effectiveness of Betaserc® (Betahistine Dihydrochloride) in Patients With Vestibular Vertigo in Routine Practice

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

vestibular vertigo

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Abbott

Responsible Party

Principal Investigators

Jean-Pascal Berrou, MD

Locations

Site reference ID 89414

Research facility ID ORG-000838

Site reference ID 89433

Site reference ID 89454

Site reference ID 89419

Research facility ID ORG-000837

Site reference ID 94374

Site reference ID 89416

Site reference ID 89435

Research facility ID ORG-000841

Site reference ID 89453

Site reference ID 89456

Site reference ID 89418

Site reference ID 89415

Site reference ID 89455

Research facility ID ORG-000345

Site reference ID 93715

Site reference ID 93713

Site reference ID 93454

Site reference ID 93475

Site reference ID 93714

Site reference ID 93474

Site reference ID 95738

Site reference ID 93455

Countries

Other Identifiers

P13-972