Effectiveness of Betaserc® (Betahistine Dihydrochloride) in Patients With Vestibular Vertigo in Routine Practice
- Conditions
- Vertigo
- Registration Number
- NCT01759251
- Lead Sponsor
- Abbott
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 309
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Scale for Vestibular Vertigo Severity Level and Clinical Response Evaluation (SVVSLCRE) Up to 2 months Number of patients with clinical response on treatment determined with SVVSLCRE
- Secondary Outcome Measures
Name Time Method Change of the Patient's Clinical Conditions of Vestibular Vertigo From Baseline to the End of Observational Treatment Period From Day 0 to 2 months determined with the Scale for Vestibular Vertigo Severity Level and Clinical Response Evaluation (SVVSLCRE)
Change of Vestibular Vertigo Attacks Frequency From Baseline to the End of Observational Treatment Period From Day 0 to 2 months Change of Vestibular Vertigo Attacks Frequency From the End of Observational Treatment Period to the End of Follow-up Period From 2 months to 4 months Overall Clinical Response Assessed by Physician up to 2 months determined with a four-point-scale, where 4 = excellent, 3 = good, 2 = fair, and 1 = poor.
Overall Clinical Response Assessed by Patient up to 2 months determined with a four-point-scale, where 4 = excellent, 3 = good, 2 = fair, and 1 = poor.
Clinical Response as Improvement of Vertigo Associated Symptoms Evaluated by Physician up to 2 months vertigo associated symptoms: tinnitus, hearing loss, nausea, vomiting, faintness and headache; determined with a four-point-scale, where 4 = excellent, 3 = good, 2 = fair, and 1 = poor.
Clinical Response as Improvement of Vertigo Associated Symptoms Evaluated by Patient up to 2 months vertigo associated symptoms: tinnitus, hearing loss, nausea, vomiting, faintness and headache; determined with a four-point-scale, where 4 = excellent, 3 = good, 2 = fair, and 1 = poor.
Trial Locations
- Locations (24)
Research facility ID ORG-000345
🇺🇦Donetsk, Ukraine
Site reference ID 89414
🇷🇺Belgorod, Russian Federation
Site reference ID 89433
🇷🇺Kazan, Russian Federation
Site reference ID 89418
🇷🇺Saratow, Russian Federation
Site reference ID 89456
🇷🇺St. Petersburg, Russian Federation
Site reference ID 93713
🇺🇦Kharkiv, Ukraine
Site reference ID 89455
🇷🇺Volgograd, Russian Federation
Site reference ID 93714
🇺🇦Sevastopol, Ukraine
Site reference ID 93474
🇺🇦Simferopol, Ukraine
Site reference ID 93715
🇺🇦Ivano-Frankivsk, Ukraine
Site reference ID 93475
🇺🇦Mykolaiv, Ukraine
Site reference ID 95738
🇺🇦Zaporizhzhia, Ukraine
Research facility ID ORG-000838
🇷🇺Irkutsk, Russian Federation
Site reference ID 89415
🇷🇺Ufa, Russian Federation
Site reference ID 93454
🇺🇦Kiev, Ukraine
Site reference ID 89454
🇷🇺Moscow, Russian Federation
Site reference ID 89416
🇷🇺Moscow, Russian Federation
Site reference ID 89435
🇷🇺Novosibirsk, Russian Federation
Site reference ID 89453
🇷🇺Rostov-on-Don, Russian Federation
Site reference ID 93455
🇺🇦Zaporizhzhia, Ukraine
Research facility ID ORG-000837
🇷🇺Moscow, Russian Federation
Site reference ID 94374
🇷🇺Moscow, Russian Federation
Research facility ID ORG-000841
🇷🇺Odintsovo, Russian Federation
Site reference ID 89419
🇷🇺Moscow, Russian Federation