EUCTR2011-004025-27-CZ进行中（未招募）1 期
Efficacy and safety of a fixed combination of cinnarizine 20 mg and dimenhydrinate 40 mg vs betahistine dihydrochloride 16 mg in patients with vertigo of peripheral origin. A multi-centre, double-blind, randomised, active-controlled, stratified two-parallel group clinical study
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 306
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
- •written Informed Consent of the patient
- •patient has vertigo sensations of peripheral-vestibular origin, e.g. Menière-like symptoms
- •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 178
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 46
排除标准
- •simultaneous participation in another clinical study
- •patient did not voluntarily sign the informed consent form
- •intake of antivertiginous or cerebrovascularly active medication that cannot be discontinued
- •known allergic reactions to one of the active substances of the study medication (cinnarizine, dimenhydrinate and/or betahistine dihydrochloride)
- •known hypersensitivity to various medicaments
- •suspicion of alcohol and/or drug abuse
- •psychiatric diseases, insanity
- •epilepsy or convulsive fits
- •acute infections
- •severe chronic or terminal diseases (cancer, tuberculosis)
- •any disease that could affect absorption, metabolism or elimination of the study medication
- •acute poisoning
- •suspected pregnancy / nursing period / women of child-bearing potential, if no safe contraception can be guaranteed during the study
- •chronic inflammatory middle ear diseases
- •Parkinson’s disease
- •suspected compressive intracranial processes
- •suspected narrow-angle glaucoma
- •suspected prostate adenoma with formation of residual urine in the bladder
- •severe renal insufficiency
- •chronic liver disease
- •treatment with aminoglycosidic antibiotics
- •treatment with monoaminooxidase inhibitors, tricyclic antidepressants, para-sympatholytics, glucocorticoids and/or heparin that cannot be discontinued
- •phaeochromocytoma
- •peptic ulcer
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