Clinical trial NCT01759251: Effectiveness of Betaserc® (Betahistine Dihydrochloride) in Patients With Vestibular Vertigo in Routine Practice
Official title: Post-marketing Observational Program of Betaserc® (Betahistine Dihydrochloride) to Evaluate Effectiveness in Patients With Vestibular Vertigo in Routine Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vertigo
Keywords: Meniere Disease
Betahistine Dihydrochloride
Vertigo
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2013-01-03
Enrollment: 309
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: outpatients with vestibular vertigo

Brief summary: 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: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Scale for Vestibular Vertigo Severity Level and Clinical Response Evaluation (SVVSLCRE)
timeFrame: Up to 2 months
Secondary outcomes:
measure: Change of the Patient's Clinical Conditions of Vestibular Vertigo From Baseline to the End of Observational Treatment Period
timeFrame: From Day 0 to 2 months
measure: Change of Vestibular Vertigo Attacks Frequency From Baseline to the End of Observational Treatment Period
timeFrame: From Day 0 to 2 months
measure: Change of Vestibular Vertigo Attacks Frequency From the End of Observational Treatment Period to the End of Follow-up Period
timeFrame: From 2 months to 4 months
measure: Overall Clinical Response Assessed by Physician
timeFrame: up to 2 months
measure: Overall Clinical Response Assessed by Patient
timeFrame: up to 2 months
measure: Clinical Response as Improvement of Vertigo Associated Symptoms Evaluated by Physician
timeFrame: up to 2 months
measure: Clinical Response as Improvement of Vertigo Associated Symptoms Evaluated by Patient
timeFrame: up to 2 months
Other outcomes:
Locations:
city: Belgorod
country: Russian Federation
facility: Site reference ID 89414
city: Irkutsk
country: Russian Federation
facility: Research facility ID ORG-000838
city: Kazan
country: Russian Federation
facility: Site reference ID 89433
city: Moscow
country: Russian Federation
facility: Site reference ID 89454
city: Moscow
country: Russian Federation
facility: Site reference ID 89419
city: Moscow
country: Russian Federation
facility: Research facility ID ORG-000837
city: Moscow
country: Russian Federation
facility: Site reference ID 94374
city: Moscow
country: Russian Federation
facility: Site reference ID 89416
city: Novosibirsk
country: Russian Federation
facility: Site reference ID 89435
city: Odintsovo
country: Russian Federation
facility: Research facility ID ORG-000841
city: Rostov-on-Don
country: Russian Federation
facility: Site reference ID 89453
city: Saratow
country: Russian Federation
facility: Site reference ID 89418
city: St. Petersburg
country: Russian Federation
facility: Site reference ID 89456
city: Ufa
country: Russian Federation
facility: Site reference ID 89415
city: Volgograd
country: Russian Federation
facility: Site reference ID 89455
city: Donetsk
country: Ukraine
facility: Research facility ID ORG-000345
city: Ivano-Frankivsk
country: Ukraine
facility: Site reference ID 93715
city: Kharkiv
country: Ukraine
facility: Site reference ID 93713
city: Kiev
country: Ukraine
facility: Site reference ID 93454
city: Mykolaiv
country: Ukraine
facility: Site reference ID 93475
city: Sevastopol
country: Ukraine
facility: Site reference ID 93714
city: Simferopol
country: Ukraine
facility: Site reference ID 93474
city: Zaporizhzhia
country: Ukraine
facility: Site reference ID 95738
city: Zaporizhzhia
country: Ukraine
facility: Site reference ID 93455
Study officials:
affiliation: Abbott
name: Jean-Pascal Berrou, MD
role: STUDY_DIRECTOR
References: