Post-marketing Observational Program of Betaserc® (Betahistine Dihydrochloride) to Evaluate Effectiveness in Patients With Vestibular Vertigo in Routine Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 309
- 试验地点
- 24
- 主要终点
- Scale for Vestibular Vertigo Severity Level and Clinical Response Evaluation (SVVSLCRE)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Scale for Vestibular Vertigo Severity Level and Clinical Response Evaluation (SVVSLCRE)
时间窗: Up to 2 months
Number of patients with clinical response on treatment determined with SVVSLCRE
次要结局
- Clinical Response as Improvement of Vertigo Associated Symptoms Evaluated by Physician(up to 2 months)
- 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)
- 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)
- Overall Clinical Response Assessed by Patient(up to 2 months)
- Clinical Response as Improvement of Vertigo Associated Symptoms Evaluated by Patient(up to 2 months)