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
- Conditions
- Caroverine infusions have been used successfully in Austria to treat cochlear-synaptic tinnitus. This treatment is very time consuming and needs a constant monitoring of the physician.This study will investigate the efficacy and safety of caroverine eardrops for transtympanic treatment of tinnitus.The aim is to ascertain whether the results of the proof of concept study using a 1,5 % solution can be reproduced.
- Registration Number
- EUCTR2009-018046-38-AT
- Lead Sponsor
- Phafag AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
•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
•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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method