跳至主要内容
临床试验/EUCTR2005-000752-32-DE
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.

研究者

发起方
Klinikum Grosshadern

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