ISRCTN44359668已完成未知
Medical treatment of Meniere's disease with betahistine: a placebo-controlled, dose-finding study
niversity Hospital Grosshadern (Klinikum Grosshadern) (Germany) - Department of Neurology0 个研究点目标入组 186 人开始时间: 2007年9月12日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 186
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Definite Meniere's disease according to the American Academy of Ophthalmology and Otolaryngology, Head and Neck Surgery:
- •1.1. Two or more attacks of vertigo, each lasting more than 20 minutes
- •1.2. Audiometrically documented hearing loss in at least one examination
- •1.3. Tinnitus or aural fullness in the affected ear
- •1.4. Other causes excluded
- •2. At least two attacks of Meniere's disease per month for at least three subsequent months
- •3. Aged 18 to 80 years
- •4. Written informed consent to all protocol-specified procedures
排除标准
- •1. Other vestibular disorders such as vestibular migraine or phobic postural vertigo
- •2. Contraindications for treatment with betahistine-dihydrochloride, such as:
- •2.1. Asthma bronchiale
- •2.2. Pheochromacytoma
- •2.3. Pregnancy or breast-feeding
- •2.4. Severe dysfunction of kidneys or liver
- •2.5. Ulcer of the stomach or duodenum
- •2.6. Tumours
- •2.7. Severe coronary heart disease
- •2.8. Treatment with other antihistamines
研究者
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