EUCTR2005-000752-32-DE进行中(未招募)不适用
Medical treatment of Menière’s disease with betahistine:a placebo-controlled, dose-finding study
Klinikum Grosshadern0 个研究点开始时间: 2005年6月15日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Definite Ménière’s disease according to the American Academy of Ophthalmology and Otolaryngology, Head and Neck Surgery: Two or more attacks of vertigo, each lasting more than 20 minutes; audiometrically documented hearing loss in at least one examination;tinnitus or aural fullness in the affected ear; other causes excluded.
- •Further: at least two attacks of Ménière’s disease per month for at least 3 subsequent months. Age: 18 to 80 yrs; written informed consent to all protocol-specified procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Other vestibular disorders such as vestibular migraine or phobic postural vertigo; contraindications for treatment with betahistine-dihydrochloride, such as asthma bronchiale, pheochromacytoma, pregnancy or breast-feeding, severe dysfunction of kidneys or liver, ulcer of the stomach or duodenum, tumors, severe coronary heart disease, treatment with other antihistamines.
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