EUCTR2009-018046-38-AT进行中（未招募）不适用
Double blind, placebo-controlled randomized clinical trial to evaluate the efficacy and safety of a transtympanic treatment of tinnitus with caroverine - Caroverin and inner ear diseases
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Phafag AG
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
- •Men or women aged at least eighteen
- •Written consent to take part in the study after receiving information from the trial physician
- •Decompensated tinnitus with a subjective tinnitus rating of 3 to 10 (0 = no tinnitus 10 = agonising tinnitus).
- •Sudden Hearing Loss
- •Morbus Menière
- •Blast injury
- •Presbyacusis
- •chron. Otitis media
- •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
- •Women of childbearing age who are not using adequate contraception or who are (or plan to become) pregnant (a pregnancy test must be carried out by a doctor once a month in Austria) or are lactating
- •If there are solid reasons to doubt that the patient would be willing and able to cooperate
- •Subjects who have taken part in another clinical trial within the 30 days preceding the start of this study or during this study
- •Known intolerance of/hypersensitivity to caroverine
- •Pulse-synchronous tinnitus
- •Tinnitus caused by malpostition of the jaw bone (bruxism)
- •Eardrum perforation
- •Retrocochlear hearing disorder
- •Patients who have previously had a barotrauma
- •Diving accident, decompression sickness
- •Patients who have previously had a fracture of the petrous bone
- •Subjects suffering from acute or chronic accompanying conditions that according to the current state of scientific knowledge could affect the parameters used in this study to such an extent as to make it impossible to perform an objective assessment of those parameters (NYHA stage IV, cancer, HIV etc., Wallenbergsyndrom, Massive hypotension, Glaucoma)
- •Accompanying conditions that according to the current state of scientific knowledge could affect the parameters used in this study to such an extent as to make it impossible to perform an objective assessment of those parameters, particularly ear conditions, including any conditions affecting the other ear
- •Accompanying medication that according to the current state of scientific knowledge are likely to affect the measurement techniques used in this study or the results obtained (e.g. accompanying treatment with cytostatics, aminoglycoside antibiotics, loop diuretics (furosemide, etacryn acid), psychopharmaceuticals, muscle relaxants, benzodiazepines, salicylates, quinine and/or caroverine within the three days preceding the start of the study)
- •(Intravenous) drug treatment for tinnitus within the seven days preceding the start of the study where the total duration of the course is less than four weeks
- •Diseases or conditions that may be associated with an altered perception or processing of stimuli, e.g. mental illness
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